K983147 is an FDA 510(k) clearance for the 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. This device is classified as a Reagents, Test, Tetrahydrocannabinol (Class II - Special Controls, product code DKE).
Submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on September 28, 1998, 20 days after receiving the submission on September 8, 1998.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K983147 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 1998 |
| Decision Date | September 28, 1998 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DKE — Reagents, Test, Tetrahydrocannabinol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |