510(k) K991084 ยท DIS Enzyme Immunoassay, Barbiturate
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
| 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 K991084
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.