FDA 510(k) Application Details - K170938

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K170938
Device Name	Calibrator, Secondary
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Lisa K. Klinedinst Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2017
Decision Date	04/26/2017
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