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Astute Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K171482NEPHROCHECK Test SystemNovember 16, 2017
K153165NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration VeriJune 1, 2016
DEN130031NEPHROCHECK TEST SYSTEMSeptember 5, 2014