Panels › Hematology › Product code DAT · Class 2
Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
Regulation 864.7340
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 DAT
| Company | 510(k)s | Recalls |
|---|---|---|
| Medishield, Inc. | 1 | 0 |
| Organon Teknika Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 1994 | K924892 | FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM Organon Teknika Corp. | DAT |
| Sep 27, 1978 | K781103 | SPECTRASCAN Medishield, Inc. | DAT |
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