Panels › Clinical Toxicology › Product code DLP · Class 2
Radioimmunoassay, Diphenylhydantoin
Regulation 862.3350
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DLP
| Company | 510(k)s | Recalls |
|---|---|---|
| Amersham Corp. | 1 | 0 |
| Bio-Rad | 1 | 0 |
| Colony Laboratories, Inc. | 1 | 0 |
| Kallestad Laboratories, Inc. | 1 | 0 |
| Ventrex Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 1989 | K894527 | FPR PHENYTOIN KIT Colony Laboratories, Inc. | DLP |
| Jul 10, 1981 | K811775 | KALLESTAD ANTISERA TO PHENYTOIN Kallestad Laboratories, Inc. | DLP |
| Jan 11, 1980 | K792640 | FLUOROMATIC PHENYTOIN FIA Bio-Rad | DLP |
| Oct 17, 1979 | K791896 | CENTRIA PHENYTOIN RIA TEST SET Ventrex Laboratories, Inc. | DLP |
| Jun 17, 1977 | K770779 | PHENYTOIN RIA KIT Amersham Corp. | DLP |
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