Home / Companies / Astute Medical, Inc.

Astute Medical, Inc.

FDA Regulatory Profile

Astute Medical, Inc. appears in FDA public data with 0 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on November 16, 2017.

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

FDA data resources