MATRITECH NMP22(TM) TEST KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Premarket Approval P940035

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.

Pre-market Approval Supplement Details

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.

DeviceMATRITECH NMP22(TM) TEST KIT
Classification NameSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
Generic NameSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
ApplicantALERE SCARBOROUGH, INC
Date Received1994-11-07
Decision Date1996-07-02
Notice Date1996-12-09
PMAP940035
SupplementS
Product CodeNAH
Docket Number96M-0462
Advisory CommitteeImmunology
Expedited ReviewNo
Combination Product No
Applicant Address ALERE SCARBOROUGH, INC 10 Southgate Road scarborough, ME 04074

Supplemental Filings

Supplement NumberDateSupplement Type
P940035Original Filing
S017 2022-02-08 Normal 180 Day Track No User Fee
S016 2021-05-27 30-day Notice
S015 2018-04-18 30-day Notice
S014 2017-01-30 30-day Notice
S013 2016-08-16 30-day Notice
S012 2016-04-06 30-day Notice
S011 2015-07-01 30-day Notice
S010 2013-07-10 Special (immediate Track)
S009 2013-03-18 30-day Notice
S008 2010-11-22 Normal 180 Day Track No User Fee
S007 2011-07-27 Normal 180 Day Track No User Fee
S006 2011-05-11 Normal 180 Day Track No User Fee
S005 2008-05-16 Normal 180 Day Track No User Fee
S004 2008-03-27 Normal 180 Day Track No User Fee
S003 2002-09-16 Normal 180 Day Track
S002 1999-07-23 Panel Track
S001 1996-12-16 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
10811877010637 P940035 000
10811877010545 P940035 000

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