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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Valproic Acid
510(k) Number K031870
Device Name SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Applicant Contact MARY BETH TANG
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Correspondent Contact MARY BETH TANG
Regulation Number862.3645
Classification Product Code
LEG  
Date Received06/17/2003
Decision Date 07/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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