K000494 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT. This device is classified as a Colorimetry, Acetaminophen (Class II - Special Controls, product code LDP).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on April 14, 2000, 59 days after receiving the submission on February 15, 2000.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3030.
| 510(k) Number | K000494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2000 |
| Decision Date | April 14, 2000 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LDP — Colorimetry, Acetaminophen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3030 |