K103373 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722. This device is classified as a Colorimetry, Cholinesterase (Class I - General Controls, product code DIH).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 7, 2011, 82 days after receiving the submission on November 17, 2010.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3240.
| 510(k) Number | K103373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2010 |
| Decision Date | February 07, 2011 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIH — Colorimetry, Cholinesterase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3240 |