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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 NameNMP22 BLADDERCHEK TEST KIT
Classification Namesystem,test,tumor marker,for detection of bladder cancer
Generic Namecarcinoma of urinary tract test kit
ApplicantALERE SCARBOROUGH, INC
PMA NumberP940035
Supplement NumberS006
Date Received05/11/2011
Decision Date11/15/2011
Product Code
NAH[ Registered Establishments with NAH ]
Advisory Committee Immunology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing site located at alere scarborough, inc. In scarborough, maine.
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