Panels › Clinical Toxicology › Product code ODW · Class 2
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Regulation 862.3360
0510(k)s in 12 months (6 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in ODW
| Company | 510(k)s | Recalls |
|---|---|---|
| Nanosphere, Inc. | 1 | 1 |
| Akonni Biosystems, Inc. | 1 | 0 |
| Autogenomics, Incorporated | 1 | 0 |
| Genmark Diagnostics, Incorporated | 1 | 0 |
| Osmetech Molecular Diagnostics | 1 | 0 |
| Trimgen Corporation | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2008 | Nanosphere, Inc. Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system; Nanosphere, Inc., 4088 Commercial Ave., Northbrook, IL 6006 Terminated |
ODW | K070804 |
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