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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K032287
Device Name MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd.,M/S W-104
Box 8000
Brea,  CA  92822
Applicant Contact KIM WALKER
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd.,M/S W-104
Box 8000
Brea,  CA  92822
Correspondent Contact KIM WALKER
Regulation Number862.1150
Classification Product Code
JIX  
Date Received07/24/2003
Decision Date 08/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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