FDA 510(k) Application Details - K153165

Device Classification Name	More FDA Info for this Device
510(K) Number	K153165
Device Name	NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit
Applicant	ASTUTE MEDICAL, INC 3550 GENERAL ATOMICS COURT BUILDING 2, R 432 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Karin Hughes Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2015
Decision Date	06/01/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review