The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Precision Point Of Care Blood Glucose Test Strip With True Measure Technology.
| Device ID | K021960 |
| 510k Number | K021960 |
| Device Name: | PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | ABBOTT LABORATORIES 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Contact | Janet S Connolly |
| Correspondent | Janet S Connolly ABBOTT LABORATORIES 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-14 |
| Decision Date | 2002-08-16 |
| Summary: | summary |