Cleared Traditional

SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722

K103373 · Beckman Coulter, Inc. · Toxicology
Feb 2011
Decision
82d
Days
Class 1
Risk

About This 510(k) Submission

K103373 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722, 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 review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number K103373 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DIH — Colorimetry, Cholinesterase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3240

Similar Devices — DIH Colorimetry, Cholinesterase

All 25
CHOLINESTERASE GEN.2 TEST SYSTEM
K061093 · Roche Diagnostics Corp. · Jul 2006
SENTINEL CHOLINESTERASE LIQUID
K051444 · Sentinel Ch. Srl · Jun 2005
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
K030045 · Olympus America, Inc. · Feb 2003
WIENER LAB COLINESTERASA AA
K023992 · Wiener Laboratories Saic · Feb 2003
ADVIA 1650 CHOLINESTERASE ASSAY
K013750 · Bayer Diagnostics Corp. · Jan 2002
CARESIDE CHOLINESTERASE
K002792 · Careside, Inc. · Nov 2000