The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Rotavirus (rtv) Assay.
| Device ID | K972895 |
| 510k Number | K972895 |
| Device Name: | VIDAS ROTAVIRUS (RTV) ASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Terry Mcgovern |
| Correspondent | Terry Mcgovern BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-05 |
| Decision Date | 1997-10-03 |
| Summary: | summary |