Panels › Immunology › Product code OAU · Class 2
Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
Regulation 866.6030
0510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OAU
| Company | 510(k)s | Recalls |
|---|---|---|
| Wako Chemicals USA, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2007 | K062368 | WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 Wako Chemicals USA, Inc. | OAU |
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