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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameOlympus AU 400  {SYVA EMIT 2000 CARBAMAZEPINE ASSAY} 
Document NumberK010814
Analyte NameCarbamazepine
Analyte SpecialtyToxicology / TDM
ComplexityMODERATE
Effective Date07/06/2001
Device Classification Name enzyme immunoassay, carbamazepine
510(k) Number K010814
Device Name EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
Original Applicant
SYVA CO., DADE BEHRING, INC.
p.o. box 49013
3403 yerba buena road
san jose,  CA  95135
Original Contact virginia singer
Regulation Number862.3645
Classification Product Code
KLT  
Date Received03/19/2001
Decision Date 04/13/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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