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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Cholinesterase
510(k) Number K103373
Device Name SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
Applicant
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea,  CA  92821
Applicant Contact Yvette Lloyd
Correspondent
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea,  CA  92821
Correspondent Contact Yvette Lloyd
Regulation Number862.3240
Classification Product Code
DIH  
Date Received11/17/2010
Decision Date 02/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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