510(k) K130082 ยท DKZ Enzyme Immunoassay, Amphetamine
GENPRIME DRUGS OF ABUSE READER SYSTEM
| Applicant | Genprime, Inc., Oms River NJ, US |
| Decision | Substantially Equivalent, Dec 20, 2013 |
| Received | Jan 14, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130082
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.