The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas C. Difficile Toxin A Ii Assay.
| Device ID | K964887 |
| 510k Number | K964887 |
| Device Name: | VIDAS C. DIFFICILE TOXIN A II ASSAY |
| Classification | Reagents, Clostridium Difficile Toxin |
| 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 | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-06 |
| Decision Date | 1997-04-08 |
| Summary: | summary |