FDA 510(k) Applications for Medical Device Product Code "PIG"

FDA 510(k) Number Applicant Device Name Decision Date
K153165 ASTUTE MEDICAL, INC NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit 06/01/2016
DEN130031 ASTUTE MEDICAL, INC NEPHROCHECK TEST SYSTEM 09/05/2014
K171482 Astute Medical, Inc. NEPHROCHECK Test System 11/16/2017
K210793 bioMΘrieux SA VIDAS NEPHROCHECK 07/08/2022


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