510(k) K120466 ยท NTI Drug Metabolizing Enzyme Genotyping Systems
VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Nov 6, 2012 |
| Received | Feb 15, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120466
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2014 | Nanosphere, Inc. Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Terminated |
NTI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.