FDA 510(k) Application Details - K193103

Device Classification Name	System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry   More FDA Info for this Device
510(K) Number	K193103
Device Name	System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Applicant	PerkinElmer Inc. 940 Winter Street Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Eva Nalian 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	11/08/2019
Decision Date	02/07/2020
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