K983501 is an FDA 510(k) clearance for the ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/. This device is classified as a High Pressure Liquid Chromatography, Methamphetamine (Class II - Special Controls, product code LAG).
Submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on December 18, 1998, 73 days after receiving the submission on October 6, 1998.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K983501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1998 |
| Decision Date | December 18, 1998 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | LAG — High Pressure Liquid Chromatography, Methamphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3610 |