510(k) K860046 ยท DLZ Enzyme Immunoassay, Phenobarbital
DETERMINATION OF PHENOBARBITAL
| Applicant | Clinical Data, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Jan 22, 1986 |
| Received | Jan 6, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860046
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.