510(k) K043576 ยท NTI Drug Metabolizing Enzyme Genotyping Systems
ROCHE AMPLICHIP CYP450 TEST
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jan 10, 2005 |
| Received | Dec 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2007 | Roche Molecular Systems, Inc. AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics Terminated |
NTI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.