510(k) K070804 ยท ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Sep 17, 2007 |
| Received | Mar 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070804
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.