510(k) K141647 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
| Applicant | Healgen Scientific,, LLC, Gaithersburg MD, US |
| Decision | Substantially Equivalent, Jul 17, 2014 |
| Received | Jun 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141647
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.