The following data is part of a premarket notification filed by Serono-baker Diagnostics, Inc. with the FDA for Serozyme Cortisol Test Kit.
| Device ID | K903975 |
| 510k Number | K903975 |
| Device Name: | SEROZYME CORTISOL TEST KIT |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Contact | Bowman |
| Correspondent | Bowman SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1991-01-23 |