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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.
 
DeviceBREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR
Classification Nametest, urea adult and pediatric (breath),
Generic Nametest, urea adult and pediatric (breath),
Regulation Number866.3110
Applicant
OTSUKA AMERICA PHARMACEUTICAL, INC.
2440 research blvd.
rockville, MD 20850
PMA NumberP100025
Supplement NumberS004
Date Received02/01/2013
Decision Date05/29/2013
Product Code
OZA[ Registered Establishments with OZA ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE LABELING FOR THE BREATHTEK® UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0, INCLUDING THE PACKAGE INSERT AND HOW TO GUIDE.
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