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Cardiochek Regulatory Status Report: Updated 11/15/02
510(k) Clearances and CLIA Waivers
| 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 (Professional) | 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 (Professional) | 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 Professional 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 |