CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name PerkinElmer MSMS Quattro Micro Newborn Screening System (NeoBase)   Document Number K083130 Analyte Name Proline Analyte Specialty General Chemistry Complexity HIGH Effective Date 07/16/2009 Device Classification Name system, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry 510(k) Number K083130 Device Name NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 Applicant PERKINELMER, INC. 8275 carloway road indianapolis,  IN  46236 Contact kay a taylor Regulation Number 862.1055 Classification Product Code NQL   Date Received 11/13/2008 Decision Date 07/09/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Clinical Chemistry Review Advisory Committee Clinical Chemistry Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No