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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 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 NumberS006
Date Received01/24/2014
Decision Date02/19/2014
Product Code
OZA[ Registered Establishments with OZA ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the changes to the releasing specification for 13c-urea to comply with the usp monograph changes.
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