The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Cortisol (cort) Assay & Serum Free Dilutent.
| Device ID | K931031 |
| 510k Number | K931031 |
| Device Name: | VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT |
| Classification | Fluorometric, Cortisol |
| Applicant | BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Vicki Anastasi |
| Correspondent | Vicki Anastasi BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | JFT |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-01 |
| Decision Date | 1993-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026097295 | K931031 | 000 |