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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
Generic NameTest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantMeridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati, OH 45244
PMA NumberP100025
Supplement NumberS012
Date Received01/09/2017
Decision Date03/30/2017
Withdrawal Date06/16/2025
Product Code OZA 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for software upgrade from Version 1.1 to Version 2.0
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