510(k) K935042 ยท DKZ Enzyme Immunoassay, Amphetamine
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jan 25, 1994 |
| Received | Oct 21, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935042
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.