510(k) K001225 ยท DKZ Enzyme Immunoassay, Amphetamine
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, May 17, 2000 |
| Received | Apr 17, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001225
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.