510(k) K071644 ยท DLZ Enzyme Immunoassay, Phenobarbital
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 12, 2007 |
| Received | Jun 15, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071644
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.