FDA 510(k) Application Details - K173829

Device Classification Name	More FDA Info for this Device
510(K) Number	K173829
Device Name	NeoLSD MSMS kit
Applicant	Wallac Oy, a subsidiary of PerkinElmer 940 Winter Street Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Kay A Taylor Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2017
Decision Date	07/18/2018
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