FDA 510(k) Application Details - K161494

Device Classification Name	Alkaline Picrate, Colorimetry, Creatinine   More FDA Info for this Device
510(K) Number	K161494
Device Name	Alkaline Picrate, Colorimetry, Creatinine
Applicant	Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, PO Box 6101 MS 514 Newark, DE 19711 US Other 510(k) Applications for this Company
Contact	Laura J. Duggan Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	CGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2016
Decision Date	11/15/2016
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