FDA 510(k) Application Details - K173568

Device Classification Name	System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry   More FDA Info for this Device
510(K) Number	K173568
Device Name	System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Applicant	Wallac Oy, Subsidiary of PerkinElmer, Inc. 940 Winter Street Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Brian Carney Other 510(k) Applications for this Contact
Regulation Number	862.1055   More FDA Info for this Regulation Number
Classification Product Code	NQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2017
Decision Date	09/04/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review