The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Digoxin Assay.
| Device ID | K925802 |
| 510k Number | K925802 |
| Device Name: | ACCESS DIGOXIN ASSAY |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Jan Olsen |
| Correspondent | Jan Olsen BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-16 |
| Decision Date | 1993-01-13 |