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.
| Device | MATRITECH NMP22(TM) TEST KIT |
| Classification Name | System, Test, Tumor Marker, For Detection Of Bladder Cancer |
| Generic Name | System, Test, Tumor Marker, For Detection Of Bladder Cancer |
| Applicant | ALERE SCARBOROUGH, INC |
| Date Received | 1994-11-07 |
| Decision Date | 1996-07-02 |
| Notice Date | 1996-12-09 |
| PMA | P940035 |
| Supplement | S |
| Product Code | NAH |
| Docket Number | 96M-0462 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALERE SCARBOROUGH, INC 10 Southgate Road scarborough, ME 04074 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P940035 | | Original 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