The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vitek Immunodiagnostic Assay System (vidas).
| Device ID | K891385 |
| 510k Number | K891385 |
| Device Name: | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Contact | Joan L Metcalf |
| Correspondent | Joan L Metcalf VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-09 |
| Decision Date | 1989-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026152482 | K891385 | 000 |
| 03573026140427 | K891385 | 000 |