The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Blood Glucose Monitoring System, Cat No 11001.
| Device ID | K000582 |
| 510k Number | K000582 |
| Device Name: | FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP DR. Alameda, CA 94502 -7000 |
| Contact | Eve Conner |
| Correspondent | Eve Conner ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP DR. Alameda, CA 94502 -7000 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-22 |
| Decision Date | 2000-12-05 |