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 |