The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vitek Immunodiagnostic Assay System.
| Device ID | K921302 |
| 510k Number | K921302 |
| Device Name: | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Contact | Cheryl Winters-heard |
| Correspondent | Cheryl Winters-heard VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-19 |
| Decision Date | 1992-07-28 |