K014173 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR. This device is classified as a Colorimetry, Salicylate (Class II - Special Controls, product code DKJ).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 15, 2002, 57 days after receiving the submission on December 20, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3830.
| 510(k) Number | K014173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2001 |
| Decision Date | February 15, 2002 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKJ — Colorimetry, Salicylate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3830 |