The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Digoxin Enzyme Immunoassay.
| Device ID | K963835 |
| 510k Number | K963835 |
| Device Name: | DIGOXIN ENZYME IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-24 |
| Decision Date | 1996-12-10 |