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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameRoche Diagnostics Hitachi 704  
Document NumberK954145
Analyte NameComplement, total
Analyte SpecialtyGeneral Immunology
ComplexityMODERATE
Effective Date05/07/1999
Device Classification Name complement c9, antigen, antiserum, control
510(k) Number K954145
Device Name WAKO AUTOKIT CH50
Original Applicant
WAKO CHEMICALS, USA, INC.
1600 bellwood road
richmond,  VA  23237
Original Contact tonya mallory
Regulation Number866.5240
Classification Product Code
DAE  
Date Received09/05/1995
Decision Date 12/18/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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