K000410 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS. This device is classified as a Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet (Class II - Special Controls, product code DMT).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on April 10, 2000, 62 days after receiving the submission on February 8, 2000.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3040.
| 510(k) Number | K000410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2000 |
| Decision Date | April 10, 2000 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DMT — Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3040 |