The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vitek Immunodiag Assay Syst(vidas) Ferritine Assay.
| Device ID | K920952 |
| 510k Number | K920952 |
| Device Name: | VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Contact | Cheryl Winters-head |
| Correspondent | Cheryl Winters-head VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-26 |
| Decision Date | 1992-04-07 |