FDA 510(k) Application Details - K170299

Device Classification Name	More FDA Info for this Device
510(K) Number	K170299
Device Name	Ion PGM Dx System
Applicant	LIFE TECHNOLOGIES CORPORATION 5781 VAN ALLEN WAY CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	EMILY FINNEGAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2017
Decision Date	06/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review