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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.
 
DeviceBREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA)
Classification Nametest, urea adult and pediatric (breath),
Generic Nametest, urea adult and pediatric (breath),
Regulation Number866.3110
Applicant
OTSUKA AMERICA PHARMACEUTICAL, INC.
2440 research blvd.
rockville, MD 20850
PMA NumberP100025
Supplement NumberS002
Date Received08/31/2012
Decision Date05/23/2013
Product Code
OZA[ Registered Establishments with OZA ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at sharp corporation, in allentown, pa.
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