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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA)
Classification Nametest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantOTSUKA AMERICA PHARMACEUTICAL, INC.
PMA NumberP100025
Supplement NumberS003
Date Received10/12/2012
Decision Date11/06/2012
Product Code
OZA[ Registered Establishments with OZA ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to enhance the safe use of the device.
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