The following data is part of a premarket notification filed by Biomérieux Sa with the FDA for Vidas Nephrocheck.
| Device ID | K210793 |
| 510k Number | K210793 |
| Device Name: | VIDAS NEPHROCHECK |
| Classification | Acute Kidney Injury Test System |
| Applicant | bioMérieux SA 376 Chemin De L’Orme Marcy L’Etoile, FR 69280 |
| Contact | Julien Thao My |
| Correspondent | Julien Thao My bioMérieux SA 376 Chemin De L’Orme Marcy L’Etoile, FR 69280 |
| Product Code | PIG |
| CFR Regulation Number | 862.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-16 |
| Decision Date | 2022-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026616038 | K210793 | 000 |