The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vitek Immunodiagnostic Assay System.
| Device ID | K921176 |
| 510k Number | K921176 |
| Device Name: | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Contact | Winters Heard |
| Correspondent | Winters Heard VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-11 |
| Decision Date | 1992-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026156930 | K921176 | 000 |