SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722— 510(k) K103373

Name: FDA 510(k) clearance K103373
Creator: U.S. Food and Drug Administration
Published: 2011-02-07

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K103373 for SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722, Substantially Equivalent on 2011-02-07. Applicant: Beckman Coulter, Inc.. Device class: 1.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 2010-11-17
Decision date: 2011-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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