FDA 510(k) Application Details - DEN130031

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130031
Device Name	NEPHROCHECK TEST SYSTEM
Applicant	ASTUTE MEDICAL, INC 3550 GENERAL ATOMICS COURT BUILDING 2, R 636 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	06/05/2013
Decision Date	09/05/2014
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review