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FDA 510(k) Applications Submitted by KARIN HUGHES
FDA 510(k) Number
Submission Date
Device Name
Applicant
K171482
05/19/2017
NEPHROCHECK Test System
Astute Medical, Inc.
DEN130031
06/05/2013
NEPHROCHECK TEST SYSTEM
ASTUTE MEDICAL, INC
K153165
11/02/2015
NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit
ASTUTE MEDICAL, INC
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