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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBREATHTEK UBT FOR H. PYLORI 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 NumberS006
Date Received01/22/2014
Decision Date02/19/2014
Product Code
OZA[ Registered Establishments with OZA ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason change design/components/specifications/material
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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