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CLIA - Clinical Laboratory Improvement Amendments

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Test System NameINSTRUMENTATION LABORATORY (IL) ACL TOP  {HemosIL Plasmin Inhibitor} 
Document Number K073377
Analyte NameAlpha-2-Antiplasmin
Analyte SpecialtyHematology
ComplexityHIGH
Effective Date09/22/2009
Device Classification Name instrument, coagulation, automated
510(k) NumberK073377
Device NameACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
Applicant
INSTRUMENTATION LABORATORY CO.
113 hartwell ave.
lexington,  MA  02421
Contactcarol marble
Regulation Number864.5400
Classification Product Code
GKP  
Date Received12/03/2007
Decision Date 05/04/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Statement/Summary/Purged Status Summary only
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
 
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