Medical Device Manufacturer · US , Wheat Ridge , CO

Exalenz Bioscience , Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2013
5
Total
5
Cleared
0
Denied

FDA 510(k) cleared devices by Exalenz Bioscience , Ltd. Microbiology ✕

5 devices
1-5 of 5
Cleared Feb 06, 2020
BreathID Smart System
K193610 · MSQ
Microbiology · 42d
Cleared Mar 08, 2018
BreathID Hp System
K173772 · MSQ
Microbiology · 86d
Cleared Mar 08, 2018
BreathID Hp Lab System
K173777 · MSQ
Microbiology · 86d
Cleared Oct 31, 2016
BreathID Hp Lab System
K162150 · MSQ
Microbiology · 90d
Cleared May 22, 2013
BREATHID HP SYSTEM
K130524 · MSQ
Microbiology · 83d
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