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 |