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Digital Ear Thermometer,MC-514N

Omron`s new and improved `Worry Free Thermometer` features the latest technology to provide fast and precise results.With 250 scans taken per second, patients can be sure the instant reading is accurate. Gives readings in both Fahrenheit and Celsius.

Discontinued
Not for sale

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FDA Cleared 510(K) Numbers

510K # Product Cut-Off Product Code Notified: CLIA Status
K020771 One Step Drug Screen Test Card; One Step Drug Screen Test Card With Integrated Cup see below DJG; LCM; DKZ; DIS; JXM; LDJ; DIO; DPK; DJR May 15, 2002  
  AMP 1000 ng/mL      
  BAR 300 ng/mL      
  BZO 300 ng/mL      
  COC 300 ng/mL      
  MAMP 1000 ng/mL      
  MOP 300 or OPI 300 300 ng/mL      
  MTD 300 ng/mL      
  OPI 2000 2000 ng/mL      
  PCP 25 ng/mL      
  THC 50 ng/mL      
K020313 One Step Multi-Drug Multi-Line Screen Test Card; One Step Multi-Drug Multi-Line Screen Test Device see below DKZ; DIO; LDJ; DJG; LCM; LAF May 8, 2002  
  AMP 1000 ng/mL      
  COC 300 ng/mL      
  MAMP 1000 ng/mL      
  OPI 2000 2000 ng/mL      
  THC 50 ng/mL      
  PCP 25 ng/mL      
K023946 One Step Multi-Drug Multi-Line Screen Test Card; One Step Multi-Drug Multi-Line Screen Test Device see below DJC; DJG; DIS; JXM; DJR; LFG Feb. 5, 2003  
  BAR 300 ng/mL      
  BZO 300 ng/mL      
  MTD 300 ng/mL      
  MDMA 500 ng/mL      
  MOP 300 or OPI 300 300 ng/mL      
  TCA 1000 ng/mL      
K031759 Multi-Drug Multi Line Drug Screen Test Card with Integrated Cup   LDJ; DIO; DJC; DKZ; DJG; LCM; JXM; DJR; DIS; LFG August 4, 2003  
  AMP 1000 ng/mL      
  COC 300 ng/mL      
  MAMP 1000 ng/mL      
  OPI 2000 2000 ng/mL      
  MOP 300 300 ng/mL      
  THC 50 ng/mL      
  PCP 25 ng/mL      
  BZO 300 ng/mL      
  MTD 300 ng/mL      
  MDMA 500 ng/mL      
  BAR 300 ng/mL      
  TCA 1000 ng/mL      
K011673 AMP - One Step Amphetamine Test Strip; One Step Amphetamine Test Device 1000 ng/mL DKZ July 31, 2001  
K041822 AMP - One Step Amphetamine Test Strip; One Step Amphetamine Test Device 300 ng/mL DKZ July 6, 2004  
K011672 mAMP - One Step  Methamphetamine Test Strip; One Step Methamphetamine Test Device 1000 ng/mL LAF July 31, 2001  
K033299 mAMP - One Step  Methamphetamine Test Strip; One Step Methamphetamine Test Device 500 ng/mL LAF December 12, 2003  
K012824 BAR - One Step Barbiturate Test Strip; One Step Barbiturate Test Device 300 ng/mL DIS November 9, 2001  
K012300 BZO - One Step Benzodiazepine Test Strip; One Step Benzodiazepine Test Device 300 ng/mL JXM September 17, 2001  
K010841 COC - One Step Cocaine Test Strip; One Step Cocaine Test Device 300 ng/mL DIO July 9, 2001  
K032903 COC - One Step Cocaine Test Strip; One Step Cocaine Test Device 150 ng/mL DIO February 17, 2004  
K013380 MOP - One Step Opiate Test Strip; One Step Opiate Test Device 300 ng/mL DJG  December 18, 2001  
K011353 OPI - One Step Opiate Test Strip; One Step Opiate Test Device 2000 ng/mL DJG July 30, 2001  
K011730 PCP - One Step Phencyclidine Test Strip; One Step Phencyclidine Test Device 25 ng/mL LCM August 9, 2001  
K003557 THC - One Step Marijuana Test Strip; One Step Marijuana Test Device 50 ng/mL LDJ March 15, 2001  
K012595 MTD - One Step Methadone Test Strip; One Step Methadone Test Device 300 ng/mL DJR October 15, 2001  
K021526 TCA - One Step Tricyclic Antidepressants Test Strip; One Step Tricyclic Antipressants Test Device 1000 ng/mL LFG July 17, 2002  
K022589 MDMA - One Step Ecstasy Test Strip; One Step Ecstasy Test Device 500 ng/mL LAF October 28, 2002  
K033047 OXY - One Step Oxycodone Test Strip or Test Device 100 ng/mL DJG  February 17, 2004  
K040445 PPX - One Step Propoxyphene Test Strip or Test Device 300 ng/mL JXN May 19, 2004  
K023946 One Step Multi-Drug Multi-Line Screen Test Card; One Step Multi-Drug Multi-Line Screen Test Device see below DJC; DJG; DIS; JXM; DJR; LFG February 5, 2003  
  BAR 300 ng/mL      
  BZO 300 ng/mL      
  MTD 300 ng/mL      
  MDMA   500 ng/mL      
  MOP or OPI 300 ng/mL      
  TCA   1000 ng/mL      
K050050 ACON On Call Multi-Drug Home Test (AMP, THC, COC, MAMP, OPI, PCP) see above see above March 16, 2005 Waived
K010582 ACON Strep  A Rapid Test Strip   GTY 7-May-01 Waived K010582/A7 December 18, 2001
K023766 Strep A Twist Rapid Test Device   GTY 10-Feb-03 Waived
K031784 Strep A Rapid Test Device   GTY 14-Jul-03  
K024350 H. pylori Rapid Test Strip   LYR April 2, 2003  
K024350 H. pylori Rapid Test Device   LYR April 2, 2003 Whole Blood - Waived
K012252 QUIK-CHECK Ovulation Predictor Test (FLH-103/103H)   CEP 13-Sep-01 Auto Waived
K012215 QUIK-CHECK Home Pregnancy Test (FHC-102H)   LCX 7-Aug-01 Auto Waived
K993483 ACON One Step Home Pregnancy Test Strip (FHC-101H)   LCX 20-Jan-00 Auto Waived
K993065 Acon Combo Pregnancy (FHC 202)   JHI 15-Oct-99 Urine Waived  -  Serum Moderate Complexity
K993317 Acon hCG One Step Pregnancy Test Device (Urine) (FHC 102)   JHI 1-Dec-99 Waived
K993203 ACON One Step Pregnancy Test Strip (Urine) (FHC-101 & FHC-111)   JHI 1-Dec-99 Waived
K980736 ACON hCG Urine/Serum One Step Pregnancy Test (FHC-201 & FHC-211)   JHI 16-Apr-98 Urine Waived  -  Serum Moderate Complexity
K983090 ACON Midstream Pregnancy Test (FHC-103)   LCX 18-Nov-98 Auto Waived
N/A ACON LH One Step Ovulation Test Strip (Urine) (FLH-101)   CEP Exempt Auto Waived
N/A ACON LH One Step Ovulation Test Device (Urine) (FLH-102)   CEP Exempt Auto Waived
K032510 ACON Quik-Check II Midstream Home Pregnancy Test   LCX 22-Sep-03  
K032661 ACON Quik-Check II  Home Pregnancy Test Device        
K033041 ACON Quik-Check II  Home Pregnancy Test Strip     11-Dec-03  
K041685 ACON Multi-CLIN Drug Screen Test Device   DKZ, DIS, JXM, DIO, LDJ, LAF, DJG, LCM, JXN, LFG August 30, 2004 Moderate
  AMP 1000 ng/mL      
  BAR 300 ng/mL      
  BZO 300 ng/mL      
  COC 300 ng/mL      
  THC 50 ng/mL      
  MDMA 500 ng/mL      
  MOP 300 or OPI 300 300 ng/mL      
  OXY   100 ng/mL      
  PCP 25 ng/mL      
  PPX   300 ng/mL      
  TCA 1000 ng/mL      
K041743 ACON Tri-Fect Drug Screen Test Device   DKZ, DIS, JXM, DIO, LDJ, LAF, DJG, LCM, JXN, LFG September 9, 2004 Moderate
  AMP 1000 ng/mL      
  BAR 300 ng/mL      
  BZO 300 ng/mL      
  COC 300 ng/mL      
  THC 50 ng/mL      
  MDMA 500 ng/mL      
  MOP 300 or OPI 300 300 ng/mL      
  OXY   100 ng/mL      
  PCP 25 ng/mL      
  PPX   300 ng/mL      
  TCA 1000 ng/mL      
K042272 ACON Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma)   KTN Feb. 28, 2005 Waived
K042272 ACON Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma)   KTN Feb. 28, 2005 Waived


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Thermometer FAQ Instructions LifeStyle Ttips OMRON Step Study
Trouble Shooting


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