The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Sr1 Dhea-s Enzyme Immunoassay.
| Device ID | K942051 |
| 510k Number | K942051 |
| Device Name: | SR1 DHEA-S ENZYME IMMUNOASSAY |
| Classification | Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
| Applicant | SERONO DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Contact | Richard D Eckloff |
| Correspondent | Richard D Eckloff SERONO DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Product Code | JKC |
| CFR Regulation Number | 862.1245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-28 |
| Decision Date | 1994-07-13 |