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 |