510(k) K991078 ยท DKE Reagents, Test, Tetrahydrocannabinol
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
| 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 K991078
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.