510(k) K946210 ยท DLZ Enzyme Immunoassay, Phenobarbital
PHENOBARBITAL ENZYME IMMUNOASSAY
| Applicant | Diagnostic Reagents, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Feb 10, 1995 |
| Received | Dec 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946210
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.