510(k) K121065 ยท DKZ Enzyme Immunoassay, Amphetamine
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
| Applicant | Polymed Therapeutics, Inc., Gaithersburg MD, US |
| Decision | Substantially Equivalent, May 24, 2013 |
| Received | Apr 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121065
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.