The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Estradiol Ii (e2ii) Assay.
| Device ID | K955647 |
| 510k Number | K955647 |
| Device Name: | VIDAS ESTRADIOL II (E2II) ASSAY |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Terry Mcgovern |
| Correspondent | Terry Mcgovern BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-12 |
| Decision Date | 1996-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026161637 | K955647 | 000 |