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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Urea (Breath Or Blood)
510(k) Number K173777
Device Name BreathID Hp Lab System
Applicant
Exalenz Bioscience , Ltd.
4 Ha'Maayan St.
Modiin,  IL 7177872
Applicant Contact Raffi Werner
Correspondent
Medicsense USA
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact George Hattub
Regulation Number866.3110
Classification Product Code
MSQ  
Subsequent Product Code
JJQ  
Date Received12/12/2017
Decision Date 03/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02905825
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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