CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Hyphen Biomed Hemoclot Quanti. V-L  {Automated Procedure}  Document Number K083729 Analyte Name Activated Protein C (APC) Resistance Analyte Specialty Hematology Complexity MODERATE Effective Date 05/19/2009 Device Classification Name test, time, partial thromboplastin 510(k) Number K083729 Device Name HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN Applicant ANIARA DIAGNOSTICA ,LLC 6560 gove court mason,  OH  45040 Contact ola anderson Regulation Number 864.7925 Classification Product Code GGW   Subsequent Product Codes GGN   JIT   Date Received 12/16/2008 Decision Date 05/08/2009 Decision substantially equivalent - CLIA submission (CS) 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