Medical Device Manufacturer · US , Falmouth, , ME

Enterix, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2001
3
Total
3
Cleared
0
Denied

FDA 510(k) Regulatory Record - Enterix, Inc. Hematology ✕

3 devices
1-3 of 3
Cleared Oct 05, 2017
InSure ONE
K170548 · KHE
Hematology · 223d
Cleared May 04, 2006
INSURE II
K060930 · KHE
Hematology · 29d
Cleared Jan 12, 2001
!NSURE FECAL OCCULT BLOOD TEST
K002457 · KHE
Hematology · 155d
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