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 |