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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNMP22 BladderChek Test
Generic NameSystem, test, tumor marker, for detection of bladder cancer
ApplicantAbbott Diagnostics Scarborough, Inc.
10 Southgate Rd.
Scarborough, ME 04074
PMA NumberP940035
Date Received11/07/1994
Decision Date07/02/1996
Product Code NAH 
Docket Number 96M-0462
Notice Date 12/09/1996
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MATRITECH NMP22 TEST KIT. THE MATRITECH NMP22 TEST KIT IS AN ENZYME IMMUNOASSAY (EIA) FOR THE IN VITRO QUANTITATIVE DETERMINATION OF NUCLEAR MATRIX PROTEIN NMP22 IN STABILIZED VOIDED URINE.
Supplements: S006 S001 S009 S003 S002 S004 S005 S012 S014  S007 S011 
S008 S013 S010 S017 S015 S016 
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