The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Digoxin (dig).
| Device ID | K932250 |
| 510k Number | K932250 |
| Device Name: | VIDAS DIGOXIN (DIG) |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Vicki Anastasi |
| Correspondent | Vicki Anastasi BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | KXT |
| Subsequent Product Code | DKA |
| Subsequent Product Code | KDA |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-10 |
| Decision Date | 1993-09-10 |