The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Enzyme-linked Fluorescent Immunoassay.
| Device ID | K943811 |
| 510k Number | K943811 |
| Device Name: | ENZYME-LINKED FLUORESCENT IMMUNOASSAY |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| 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 | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-05 |
| Decision Date | 1994-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026156961 | K943811 | 000 |