Medical Device Manufacturer · US , Oxford , CT

Nanoentek USA, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2014
5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - Nanoentek USA, Inc. Chemistry ✕

4 devices
1-4 of 4
Cleared Jan 12, 2017
FREND Vitamin D Test System
K162754 · MRG
Chemistry · 104d
Cleared Oct 14, 2016
FREND Testosterone Test System
K153577 · CDZ
Chemistry · 304d
Cleared Feb 17, 2016
FREND™ Free T4 Test System
K152422 · CEC
Chemistry · 175d
Cleared Mar 14, 2014
FREND TSH (REAGENT CARTRIDGE)
K131928 · JLW
Chemistry · 260d
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