The following data is part of a premarket notification filed by Bayer Healthcare Llc with the FDA for Contour Next Blood Glucose Meter.
| Device ID | K121190 |
| 510k Number | K121190 |
| Device Name: | CONTOUR NEXT BLOOD GLUCOSE METER |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | BAYER HEALTHCARE LLC 555 WHITE PLAINS RD. Tarrytown, NY 10591 |
| Contact | Charles Ryan |
| Correspondent | Charles Ryan BAYER HEALTHCARE LLC 555 WHITE PLAINS RD. Tarrytown, NY 10591 |
| Product Code | LFR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-19 |
| Decision Date | 2012-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40301939697018 | K121190 | 000 |
| 40301937357501 | K121190 | 000 |
| 40301939735253 | K121190 | 000 |
| 40301939736502 | K121190 | 000 |
| 40301939737219 | K121190 | 000 |
| 10301937313100 | K121190 | 000 |
| 40301937283350 | K121190 | 000 |
| 40301937377011 | K121190 | 000 |
| 40301937379015 | K121190 | 000 |
| 40301937308503 | K121190 | 000 |