| ITEM | Description | K Number | Status | Date First
CLIA Waived
|
| PTS PANELS Glucose
Test Strips (Professional) | Glucose test | K972669 | Cleared
Jan.22, 1998 | Jul.17, 1998
|
| PTS PANELS Glucose
Test Strips (OTC) | Glucose test | K972669 | Cleared
Jan.22, 1998 | Jul.17, 1998
|
| PTS PANELS Glucose
Control | Glucose control | K972669 | Cleared
Jan.22, 1998 | Does not
apply
|
| PTS PANELS Cholesterol
(Professional) | Cholesterol test | K981493 | Cleared
July 22, 1998 |
|
| PTS PANELS Cholesterol(OTC) | Cholesterol test | K990688 | Cleared
June 24, 1999 | Aug. 19, 1999
|
| PTS PANELS Ketone
(Professional) | Ketone test | K981865 | Cleared
Feb.26, 1999 | Mar. 1, 2000
|
| PTS PANELS Ketone
(OTC) | Ketone test | K983860 | Cleared
Dec.27,1999 |
|
| PTS PANELS HDL
(Professional) | HDL test | K990247 | Cleared
May 28, 1999 |
|
| PTS PANELS HDL (OTC) | HDL test | K993377 | Cleared
Jan.13, 2000 | Feb.28,2000
|
| PTS PANELS
Triglycerides (Professionall | Triglyceride test | K991894 | Cleared
May 24, 2000 |
|
| PTS PANELS
Triglycerides (OTC) | Triglyceride test | K000586 | Cleared
July 3, 2000 | Jul. 3, 2000
|
| PTS
PANELS Creatinine Test Strips (Professional) | Creatinine test | K010456 |
Not Cleared, Moderately Complex. |
|
| CardioChek
PA | Instrument for all tests | K013173 | Cleared
Oct. 22, 2001 |
|
| Lipid Panel Test Strips
(Professional) | Multi-test strip for
cholesterol, HDL, and triglycerides | K013173 | Cleared
Oct. 22, 2001 |
|
| Q3 Glucose Analyzer
(Professional and OTC) | Hand-held amperometric
glucose analyzer | K013203 | Cleared
Nov.16, 2001 | Nov. 16, 2001
|
|
PTS
PANELS Test Strips | Glucose test | K013068 | Cleared
Nov.20, 2001 | Nov.20,2001
|
| CardioChek
PA
and OTC Glucoses | CardioChek with PTS
PANELS Test Strips (colorimetric) and PTS PANELS Advanced Glucose Test Strips
(amperometric) | K014099 | Cleared
Dec.21, 2001 | Dec.21,2001
|
| PTS PANELS Multi-Chemistry Controls | Multi-constituent controls
for use with PTS PANELS Test Strips | K022401 | Cleared
Aug.21, 2002 | Does not
apply
|
| PTS PANELS Lipid Panel
Test Strips (Professional) | Multi-test strip for
cholesterol, HDL, and triglycerides. Special
510(k) with revised claims | K022898 | Cleared
Sept. 24, 2002 | Oct. 18, 2002
|
| PTS PANELS Lipid Panel
Test Strips (OTC) | Multi-test strip for
cholesterol, HDL, and triglycerides. | K023558 | Cleared
Nov. 15, 2002 | Nov. 15, 2002
|
