K000606 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS AMPHETAMINE REAGENT. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on May 5, 2000, 72 days after receiving the submission on February 23, 2000.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K000606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2000 |
| Decision Date | May 05, 2000 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |