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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 K221896
Device Name BreathID Hp 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 Received06/30/2022
Decision Date 12/19/2022
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 Yes
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