510(k) K991082 ยท DIS Enzyme Immunoassay, Barbiturate
ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Apr 15, 1999 |
| Received | Mar 26, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991082
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.