Approval for a manufacturing site located at tripath imaging, inc. In melbane, north carolina.
| Device | BD FOCALPOINT GS IMAGING SYSTEM |
| Classification Name | Reader, Cervical Cytology Slide, Automated |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | BD DIAGNOSTICS |
| Date Received | 2009-06-25 |
| Decision Date | 2010-03-15 |
| PMA | P950009 |
| Supplement | S010 |
| Product Code | MNM |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BD DIAGNOSTICS 4025 Stirrup Creek Drive suite 400 durham, NC 27703 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P950009 | | Original Filing |
| S026 |
2022-06-15 |
30-day Notice |
| S025 |
2021-09-02 |
Real-time Process |
| S024 |
2021-03-04 |
30-day Notice |
| S023 |
2019-11-19 |
30-day Notice |
| S022 |
2019-06-05 |
Normal 180 Day Track |
| S021 |
2016-05-19 |
30-day Notice |
| S020 |
2016-03-07 |
Normal 180 Day Track No User Fee |
| S019 |
2015-04-24 |
Real-time Process |
| S018 |
2014-11-12 |
Normal 180 Day Track |
| S017 |
2013-12-02 |
Real-time Process |
| S016 |
2012-07-05 |
Real-time Process |
| S015 |
2012-03-28 |
Normal 180 Day Track |
| S014 |
2012-01-17 |
Real-time Process |
| S013 |
2011-09-15 |
Real-time Process |
| S012 |
2010-08-17 |
Special (immediate Track) |
| S011 |
2009-12-10 |
30-day Notice |
| S010 |
2009-06-25 |
Normal 180 Day Track No User Fee |
| S009 |
2009-03-26 |
Real-time Process |
| S008 |
2007-10-02 |
Panel Track |
| S007 | | |
| S006 | | |
| S005 |
2001-10-26 |
Real-time Process |
| S004 |
1999-10-01 |
Normal 180 Day Track |
| S003 |
1998-10-13 |
Normal 180 Day Track |
| S002 |
1996-06-06 |
Panel Track |
| S001 |
1995-11-06 |
Special (immediate Track) |
NIH GUDID Devices