The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vidas Clostridium Difficile Toxin A (cda) Assay.
| Device ID | K905211 |
| 510k Number | K905211 |
| Device Name: | VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | VITEK SYSTEMS, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Cheryl Winters-heard |
| Correspondent | Cheryl Winters-heard VITEK SYSTEMS, 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 | 1990-11-20 |
| Decision Date | 1991-10-11 |