The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Proesterone (prg) (30 409).
| Device ID | K965084 |
| 510k Number | K965084 |
| Device Name: | VIDAS PROESTERONE (PRG) (30 409) |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | BIOMERIEUX, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Terry Mcgovern |
| Correspondent | Terry Mcgovern BIOMERIEUX, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-19 |
| Decision Date | 1997-01-09 |
| Summary: | summary |