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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.
 
DeviceNMP22 BLADDERCHEK TEST KIT
Classification Namesystem,test,tumor marker,for detection of bladder cancer
Generic Namesystem,test,tumor marker,for detection of bladder cancer
Applicant
ALERE SCARBOROUGH, INC
10 southgate road
scarborough, ME 04074
PMA NumberP940035
Supplement NumberS004
Date Received03/27/2008
Decision Date05/20/2008
Product Code
NAH[ Registered Establishments with NAH ]
Advisory Committee Immunology
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 BINAX, INC., SCARBOROUGH, MAINE.
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