The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Lite Blood Glucose Monitoring System And Freestyle Freedom Lite Blood Glucose Monitoring System.
| Device ID | K092602 |
| 510k Number | K092602 |
| Device Name: | FREESTYLE Lite Blood Glucose Monitoring System And Freestyle Freedom Lite Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Contact | Arul Sterlin |
| Correspondent | Arul Sterlin ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-25 |
| Decision Date | 2010-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30699073710261 | K092602 | 000 |
| 30699073708275 | K092602 | 000 |
| 40699073708227 | K092602 | 000 |
| 30699073708190 | K092602 | 000 |
| 30699073708176 | K092602 | 000 |