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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 K220494
Device Name BreathID Hp Lab System, BreathID Smart System
Applicant
Meridian Bioscience Israel , Ltd.
4 Ha'Maayan St.
Modiin,  IL 7177872
Applicant Contact Raffi Werner
Correspondent
Meridian Bioscience Israel , Ltd.
4 Ha'Maayan St.
Modiin,  IL 7177872
Correspondent Contact Raffi Werner
Regulation Number866.3110
Classification Product Code
MSQ  
Subsequent Product Code
JJQ  
Date Received02/22/2022
Decision Date 06/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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