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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 K130524
FOIA Releasable 510(k) K130524
Device Name BREATHID HP SYSTEM
Applicant
Exalenz Bioscience , Ltd.
11925 W I-70 Frontage Rd. N.
Suite 900
Wheat Ridge,  CO  80033
Applicant Contact CLAY ANSELMO
Correspondent
Exalenz Bioscience , Ltd.
11925 W I-70 Frontage Rd. N.
Suite 900
Wheat Ridge,  CO  80033
Correspondent Contact CLAY ANSELMO
Regulation Number866.3110
Classification Product Code
MSQ  
Date Received02/28/2013
Decision Date 05/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01650831
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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