The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vitek Immunodiagnostic Assay System Mumps Igg Assa.
Device ID | K923903 |
510k Number | K923903 |
Device Name: | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA |
Classification | Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
Contact | Cheryl Winters-heard |
Correspondent | Cheryl Winters-heard BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
Product Code | LJY |
CFR Regulation Number | 866.3380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-04 |
Decision Date | 1993-08-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03573026064525 | K923903 | 000 |