510(k) K004034 ยท DKZ Enzyme Immunoassay, Amphetamine
MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
| Applicant | Branan Medical Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 8, 2001 |
| Received | Dec 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K004034
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.