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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 NameALERE NMP22 TEST
Classification Namesystem,test,tumor marker,for detection of bladder cancer
Generic Namecarcinoma of urinary tract test kit
ApplicantALERE SCARBOROUGH, INC
PMA NumberP940035
Supplement NumberS010
Date Received07/10/2013
Decision Date07/16/2013
Product Code
NAH[ Registered Establishments with NAH ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additions to the limitations and precautions sections of the package insert.
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