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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameBECKMAN SYNCHRON CX 7 DELTA  
Document NumberK961256
Parent Document NumberK961256
Analyte NameValproic acid
Analyte SpecialtyToxicology / TDM
ComplexityMODERATE
Effective Date06/14/1996
Device Classification Name Enzyme Immunoassay, Valproic Acid
510(k) Number K961256
Device Name SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Applicant Contact PAUL TRUJILLO
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Correspondent Contact PAUL TRUJILLO
Regulation Number862.3645
Classification Product Code
LEG  
Date Received04/01/1996
Decision Date 05/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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