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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameSebia CAPILLARYS 2 FLEX-PIERCING with HEMOGLOBINE(E)kit  
Document NumberK112550
Analyte NameHemoglobin E
Analyte SpecialtyGeneral Chemistry
ComplexityHIGH
Effective Date06/14/2012
Device Classification Name abnormal hemoglobin quantitation
510(k) Number K112550
Model 2007, 1227
Device Name CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
Original Applicant
SEBIA
400-1705 corporate drive
norcross,  GA  30096
Original Contact karen anderson
Regulation Number864.7415
Classification Product Code
GKA  
Date Received09/01/2011
Decision Date 05/25/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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