The following data is part of a premarket notification filed by Serono-baker Diagnostics, Inc. with the FDA for Sri Digoxin Enzyme Immunoassay.
| Device ID | K915602 |
| 510k Number | K915602 |
| Device Name: | SRI DIGOXIN ENZYME IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Contact | David Thomas |
| Correspondent | David Thomas SERONO-BAKER DIAGNOSTICS, INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-13 |
| Decision Date | 1992-01-17 |