510(k) K912758 ยท DKZ Enzyme Immunoassay, Amphetamine
ABUSCREEN ONLINE FOR AMPHETAMINES
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Jul 26, 1991 |
| Received | Jun 21, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912758
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.