The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vitek Immunodiagnostic Assay System Mumps Igg Assa.
| Device ID | K923903 |
| 510k Number | K923903 |
| Device Name: | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
| Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Contact | Cheryl Winters-heard |
| Correspondent | Cheryl Winters-heard BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Product Code | LJY |
| CFR Regulation Number | 866.3380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-04 |
| Decision Date | 1993-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026064525 | K923903 | 000 |