FDA 510(k) Application Details - K171482

Device Classification Name	More FDA Info for this Device
510(K) Number	K171482
Device Name	NEPHROCHECK Test System
Applicant	Astute Medical, Inc. 3550 General Atomics Ct., 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	05/19/2017
Decision Date	11/16/2017
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