510(k) K983147 ยท DKE Reagents, Test, Tetrahydrocannabinol
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
| Applicant | Princeton BioMeditech Corp., Princeton NJ, US |
| Decision | Substantially Equivalent, Sep 28, 1998 |
| Received | Sep 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983147
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.