The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Minividas Instrument.
Device ID | K923579 |
510k Number | K923579 |
Device Name: | MINIVIDAS INSTRUMENT |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
Contact | Chryl Winters-heard |
Correspondent | Chryl Winters-heard BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
Product Code | JJE |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-20 |
Decision Date | 1993-02-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03573026140441 | K923579 | 000 |