The following data is part of a premarket notification filed by Serono-baker Diagnostics, Inc. with the FDA for Sri Human Chorionic Gonadotropin Immunoenz Assay.
| Device ID | K894175 |
| 510k Number | K894175 |
| Device Name: | SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-15 |
| Decision Date | 1989-12-19 |