510(k) K863419 ยท DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
EMDS(TM) ALCOHOL TESTPACKS, #67691/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Sep 29, 1986 |
| Received | Sep 3, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863419
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.