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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 KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
Classification Nametest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantOTSUKA AMERICA PHARMACEUTICAL, INC.
PMA NumberP100025
Supplement NumberS005
Date Received07/03/2013
Decision Date04/18/2014
Product Code
OZA[ Registered Establishments with OZA ]
Advisory Committee Microbiology
Clinical Trials NCT01623154
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the addition of the pocone infrared spectrophotometer for pediatric use.
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