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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.
 
DeviceBREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE 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 NumberS003
Date Received10/12/2012
Decision Date11/06/2012
Product Code
OZA[ Registered Establishments with OZA ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to enhance the safe use of the device.
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