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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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