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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 NameBREATH TEK UBTFOR H. PYLORI KIT
Classification Nametest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantOTSUKA AMERICA PHARMACEUTICAL, INC.
PMA NumberP100025
Supplement NumberS001
Date Received03/20/2012
Decision Date09/05/2012
Product Code
OZA[ Registered Establishments with OZA ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for packaging changes for the breathtek ubt for h. Pylori kit (breathtek ubt kit) and pediatric urea hydrolysis rate calculation application (puhr-ca), version 1. 0. The packaging changes consist of new kit and shipper cartons along with new labeling on the each of these cartons.
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