The following data is part of a premarket notification filed by Serono-baker Diagnostics, Inc. with the FDA for Progesterone Serozyme Immunoenzymetric Assay.
| Device ID | K884794 |
| 510k Number | K884794 |
| Device Name: | PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Contact | R. E Tomalesky |
| Correspondent | R. E Tomalesky SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-16 |
| Decision Date | 1989-02-02 |