510(k) K864926 ยท DLZ Enzyme Immunoassay, Phenobarbital
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jan 7, 1987 |
| Received | Dec 16, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864926
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.