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AlcoMate Premium (AL7000) Breathalyzer, FULL Pack

AlcoMate Premium AL7000 includes a PRISM breathalyzer and heavy duty case. No calibration needed! Operates w/ semiconductor-oxide sensor, 4 digit back light display,one-way-flow mouthpieces, etc. Great for Prof. and Consumers.

$209.95/analyzer

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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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6633 Ashman Rd. Maria Stein, OH 45860
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