The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vitek Yeast Biochemical Card.
| Device ID | K881925 |
| 510k Number | K881925 |
| Device Name: | VITEK YEAST BIOCHEMICAL CARD |
| Classification | Kit, Identification, Yeast |
| 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 | JXB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-09 |
| Decision Date | 1988-06-16 |