|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 Name||BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)|
|Classification Name||test, urea adult and pediatric (breath),|
|Applicant||OTSUKA AMERICA PHARMACEUTICAL, INC.|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of the pocone infrared spectrophotometer for pediatric use.