The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas C. Dificile Toxin A & B (cdab) Assay.
| Device ID | K080931 |
| 510k Number | K080931 |
| Device Name: | VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Nikita S Mapp |
| Correspondent | Nikita S Mapp BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-02 |
| Decision Date | 2008-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026229146 | K080931 | 000 |