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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 HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA)
Generic NameTest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantMeridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati, OH 45244
PMA NumberP100025
Supplement NumberS003
Date Received10/12/2012
Decision Date11/06/2012
Withdrawal Date06/16/2025
Product Code OZA 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A LABELING CHANGE TO ENHANCE THE SAFE USE OF THE DEVICE.
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