The following data is part of a premarket notification filed by Serono-baker Diagnostics, Inc. with the FDA for Estradiol Serozyme Enzyme Immuno (mag Solid-phase).
| Device ID | K912318 |
| 510k Number | K912318 |
| Device Name: | ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Contact | David B Thomas |
| Correspondent | David B Thomas SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-24 |
| Decision Date | 1991-07-25 |