The following data is part of a premarket notification filed by Abott Laboratories with the FDA for Freestyle Insulinx Blood Glucose Monotioring System.
| Device ID | K152328 |
| 510k Number | K152328 |
| Device Name: | FreeStyle InsuLinx Blood Glucose Monotioring System |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | ABOTT LABORATORIES 1360 SOUTH LOOP ROAD Alameda, CA 94502 |
| Contact | Sai Sriharshada Tatavarty |
| Correspondent | Sai Sriharshada Tatavarty ABBOTT LABORATORIES 1360 SOUTH LOOP ROAD Alameda, CA 94502 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-18 |
| Decision Date | 2015-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30699073712319 | K152328 | 000 |
| 30093815711439 | K152328 | 000 |
| 00093815711452 | K152328 | 000 |
| 30093815711507 | K152328 | 000 |
| 30093815715000 | K152328 | 000 |
| 30699073712272 | K152328 | 000 |
| 30699073712289 | K152328 | 000 |
| 30699073712296 | K152328 | 000 |
| 30699073712302 | K152328 | 000 |
| 30093815711422 | K152328 | 000 |