Panels › Hematology › Product code GIR · Class 1
Reagent, Russel Viper Venom
Regulation 864.8950
0510(k)s in 12 months (16 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in GIR
| Company | 510(k)s | Recalls |
|---|---|---|
| American Diagnostica, Inc. | 1 | 1 |
| Dsrv, Inc. | 2 | 0 |
| Gradipore , Ltd. | 2 | 0 |
| Instrumentation Laboratory CO | 2 | 0 |
| Precision Biologic | 2 | 0 |
| Sigma Diagnostics, Inc. | 2 | 0 |
| Biopool AB | 1 | 0 |
| Diagnostica Stago, Inc. | 1 | 0 |
| Diatech, Inc. | 1 | 0 |
| Graoipore , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2007 | American Diagnostica, Inc. American Diagnostica Inc. ACTICLOT dPT
Reference 824 in vitro diagnostic Terminated |
GIR | K052124 |
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