The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vitek Immunodiagnostic Assay System.
| Device ID | K923122 |
| 510k Number | K923122 |
| Device Name: | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Contact | Cheryl Wintets-heard |
| Correspondent | Cheryl Wintets-heard BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Product Code | LFY |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-26 |
| Decision Date | 1992-10-26 |