Exalenz Bioscience , Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Exalenz Bioscience , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: BreathID Smart System, BreathID Hp System, BreathID Hp Lab System
5
Total
5
Cleared
0
Denied
Exalenz Bioscience , Ltd. has 5 FDA 510(k) cleared medical devices. Based in Wheat Ridge, US.
Historical record: 5 cleared submissions from 2013 to 2020. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Exalenz Bioscience , Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Medicsense USA as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Exalenz Bioscience , Ltd.
5 devices
Cleared
Feb 06, 2020
BreathID Smart System
Microbiology
42d
Cleared
CT
Mar 08, 2018
BreathID Hp System
Microbiology
86d
Cleared
CT
Mar 08, 2018
BreathID Hp Lab System
Microbiology
86d
Cleared
Oct 31, 2016
BreathID Hp Lab System
Microbiology
90d
Cleared
May 22, 2013
BREATHID HP SYSTEM
Microbiology
83d