Approval to transfer a portion of the manufacturing operations, specifically compounding of bulk reagents, to newly constructed buildings 662 and 663 within the roche penzberg, germany facility.
| Device | ELECSYS TOTAL PSA |
| Classification Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Generic Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Applicant | ROCHE DIAGNOSTICS CORP. |
| Date Received | 2012-01-31 |
| Decision Date | 2012-12-18 |
| PMA | P990056 |
| Supplement | S016 |
| Product Code | MTF |
| Advisory Committee | Immunology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P990056 | | Original Filing |
| S038 |
2021-10-18 |
30-day Notice |
| S037 |
2019-11-14 |
Normal 180 Day Track |
| S036 |
2019-01-29 |
Real-time Process |
| S035 |
2018-10-26 |
Normal 180 Day Track No User Fee |
| S034 |
2018-10-01 |
30-day Notice |
| S033 |
2018-04-17 |
Real-time Process |
| S032 |
2018-04-03 |
30-day Notice |
| S031 |
2018-03-01 |
Real-time Process |
| S030 | | |
| S029 |
2017-10-11 |
Real-time Process |
| S028 |
2017-07-31 |
Normal 180 Day Track |
| S027 |
2017-08-03 |
30-day Notice |
| S026 |
2017-05-24 |
30-day Notice |
| S025 |
2016-10-26 |
30-day Notice |
| S024 |
2016-09-07 |
Normal 180 Day Track No User Fee |
| S023 |
2016-02-18 |
30-day Notice |
| S022 |
2015-10-07 |
30-day Notice |
| S021 |
2014-04-04 |
Real-time Process |
| S020 |
2013-04-09 |
Real-time Process |
| S019 |
2012-11-30 |
30-day Notice |
| S018 | | |
| S017 |
2012-02-29 |
30-day Notice |
| S016 |
2012-01-31 |
135 Review Track For 30-day Notice |
| S015 |
2011-11-22 |
30-day Notice |
| S014 |
2011-08-01 |
Normal 180 Day Track |
| S013 |
2011-05-03 |
Normal 180 Day Track No User Fee |
| S012 |
2011-04-25 |
30-day Notice |
| S011 |
2011-04-11 |
135 Review Track For 30-day Notice |
| S010 |
2009-10-07 |
135 Review Track For 30-day Notice |
| S009 |
2008-09-02 |
30-day Notice |
| S008 |
2008-03-28 |
Normal 180 Day Track |
| S007 |
2007-08-22 |
Normal 180 Day Track |
| S006 |
2006-12-28 |
30-day Notice |
| S005 | | |
| S004 |
2006-10-05 |
Real-time Process |
| S003 |
2006-02-13 |
Normal 180 Day Track |
| S002 |
2006-01-23 |
Special (immediate Track) |
| S001 |
2001-10-09 |
Normal 180 Day Track |
NIH GUDID Devices