Panels › Clinical Toxicology › Product code DKA · Class 2
Antiserum, Digoxin
Regulation 862.3320
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in DKA
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Diagnostics, Inc. | 1 | 0 |
| Clinical Bioresearch | 1 | 0 |
| Interpore Cross International Inc | 0 | 1 |
| Pcl-Ria, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 1994 | K934003 | STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. | DKA |
| Apr 5, 1978 | K780498 | CBR-DIGOXIN ANTISERUM Clinical Bioresearch | DKA |
| Mar 17, 1978 | K780316 | RABBIT ANTIBODY TO DIGOXIN Pcl-Ria, Inc. | DKA |
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