K001225 is an FDA 510(k) clearance for the ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 17, 2000, 30 days after receiving the submission on April 17, 2000.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K001225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2000 |
| Decision Date | May 17, 2000 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |