The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Opus Fsh.
| Device ID | K911409 |
| 510k Number | K911409 |
| Device Name: | OPUS FSH |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Lori Baranauskas |
| Correspondent | Lori Baranauskas PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-01 |
| Decision Date | 1991-04-16 |