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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 K162150
Device Name BreathID Hp Lab System
Applicant
Exalenz Bioscience , Ltd.
4 Ha'Maayan St.
Modiin,  IL 7177872
Applicant Contact Raffi Werner
Correspondent
Biomedical Strategy , Ltd.
155 Bialik St.
Ramat Gan,  IL 5252346
Correspondent Contact Orna Oz
Regulation Number866.3110
Classification Product Code
MSQ  
Subsequent Product Code
JJQ  
Date Received08/02/2016
Decision Date 10/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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