The following data is part of a premarket notification filed by Serono-baker Diagnostics, Inc. with the FDA for Sr1 (fsh) Immunoenzymetric Assay.
| Device ID | K892706 |
| 510k Number | K892706 |
| Device Name: | SR1 (FSH) IMMUNOENZYMETRIC ASSAY |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Contact | Tomalesky, Phd |
| Correspondent | Tomalesky, Phd SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-14 |
| Decision Date | 1989-06-09 |