510(k) K832097 ยท DLZ Enzyme Immunoassay, Phenobarbital
PHENOBARTIAL ASSAY USE ON COBAS-BIO
| Applicant | Syva Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 11, 1983 |
| Received | Jun 29, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832097
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.