The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus Progesterone.
| Device ID | K971725 |
| 510k Number | K971725 |
| Device Name: | OPUS PROGESTERONE |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Ruth Forstadt |
| Correspondent | Ruth Forstadt BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-09 |
| Decision Date | 1997-06-18 |
| Summary: | summary |