The following data is part of a premarket notification filed by Serono-baker Diagnostics, Inc. with the FDA for Sri Luteinizing Hormone Immunoenzymetric Assay.
| Device ID | K893605 |
| 510k Number | K893605 |
| Device Name: | SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Contact | Tomalesky |
| Correspondent | Tomalesky SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-10 |
| Decision Date | 1989-06-20 |