510(k) K942501 ยท DLZ Enzyme Immunoassay, Phenobarbital
ACE CEDIA PHENOBARBITAL ASSAY
| Applicant | Schiapparelli Biosystems, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Oct 6, 1994 |
| Received | May 24, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942501
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.