Medical Device Manufacturer · US , San Diego , CA

Astute Medical, Inc. - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 2014
3
Total
2
Cleared
1
Denied
FDA 510(k) Regulatory Record - Astute Medical, Inc. Chemistry ✕
3 devices
1-3 of 3
Cleared Nov 16, 2017
NEPHROCHECK Test System
K171482 · PIG
Chemistry · 181d
Cleared Jun 01, 2016
NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit,...
K153165 · PIG
Chemistry · 212d
Not Cleared Sep 05, 2014
NEPHROCHECK TEST SYSTEM
DEN130031 · PIG
Chemistry · 457d
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