FDA 510(k) Application Details - K141220

Device Classification Name	Instrumentation For Clinical Multiplex Test Systems   More FDA Info for this Device
510(K) Number	K141220
Device Name	Instrumentation For Clinical Multiplex Test Systems
Applicant	THERMO FISHER SCIENTIFIC (LIFE TECHNOLOGIES HOLDIN BLK 33, MARSILING INDUSTRIAL, ESTATE ROAD 3, NO. 07-06 SINGAPORE 739256 SG Other 510(k) Applications for this Company
Contact	Nikki Arora Other 510(k) Applications for this Contact
Regulation Number	862.2570   More FDA Info for this Regulation Number
Classification Product Code	NSU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2014
Decision Date	05/22/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review