Panels › Immunology › Product code DDF · Class 1
Prothrombin, Antigen, Antiserum, Control
Regulation 866.5735
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DDF
| Company | 510(k)s | Recalls |
|---|---|---|
| Hoffmann-La Roche, Inc. | 1 | 0 |
| Organon Teknika Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 1991 | K910617 | NATIVE PROTHROMBIN ANTIGEN EIA Organon Teknika Corp. | DDF |
| Dec 31, 1981 | K812985 | AGGLUTEX MORPHINE TEST KIT Hoffmann-La Roche, Inc. | DDF |
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