This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Addition of a supplier manufacturing site for the production of the unicel dxi reaction vessels.
| Device | Access Hybritech PSA Assay |
| 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 | BECKMAN COULTER, INC. |
| Date Received | 2017-09-28 |
| Decision Date | 2017-10-24 |
| PMA | P850048 |
| Supplement | S048 |
| Product Code | MTF |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BECKMAN COULTER, INC. 250 South Kraemer Blvd M/s w-110 brea, CA 92822 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850048 | Original Filing | |
| S058 | 2022-02-04 | 30-day Notice |
| S057 | ||
| S056 | 2020-09-30 | Real-time Process |
| S055 | 2020-07-22 | Real-time Process |
| S054 | 2020-06-23 | Real-time Process |
| S053 | 2019-12-18 | Real-time Process |
| S052 | 2019-05-13 | Real-time Process |
| S051 | 2019-05-02 | Real-time Process |
| S050 | ||
| S049 | 2018-09-25 | Real-time Process |
| S048 | 2017-09-28 | 30-day Notice |
| S047 | ||
| S046 | 2017-06-09 | 30-day Notice |
| S045 | 2017-03-22 | Real-time Process |
| S044 | 2017-01-17 | 30-day Notice |
| S043 | 2016-10-11 | 30-day Notice |
| S042 | 2016-07-28 | 30-day Notice |
| S041 | 2015-05-07 | Real-time Process |
| S040 | 2014-11-04 | 135 Review Track For 30-day Notice |
| S039 | 2014-08-25 | Real-time Process |
| S038 | 2014-08-25 | 135 Review Track For 30-day Notice |
| S037 | 2013-12-17 | Real-time Process |
| S036 | 2013-09-26 | Special (immediate Track) |
| S035 | 2013-06-13 | Special (immediate Track) |
| S034 | 2013-04-12 | Special (immediate Track) |
| S033 | 2013-03-29 | Real-time Process |
| S032 | 2013-01-23 | Real-time Process |
| S031 | 2013-01-03 | 30-day Notice |
| S030 | ||
| S029 | ||
| S028 | 2012-10-25 | Special (immediate Track) |
| S027 | 2012-03-15 | Special (immediate Track) |
| S026 | 2011-12-23 | Real-time Process |
| S025 | 2011-01-12 | Special (immediate Track) |
| S024 | 2011-01-10 | Special (immediate Track) |
| S023 | 2007-12-19 | Real-time Process |
| S022 | 2007-05-16 | Normal 180 Day Track |
| S021 | 2007-08-21 | Panel Track |
| S020 | 2006-04-10 | Real-time Process |
| S019 | 2002-12-20 | Real-time Process |
| S018 | 2002-10-04 | Real-time Process |
| S017 | 2002-08-19 | Normal 180 Day Track |
| S016 | 1999-10-18 | Normal 180 Day Track |
| S015 | 1999-07-12 | 30-day Notice |
| S014 | 1999-05-19 | Normal 180 Day Track |
| S013 | 1999-04-27 | Normal 180 Day Track |
| S012 | 1995-10-27 | Normal 180 Day Track |
| S011 | 1995-06-14 | Special (immediate Track) |
| S010 | ||
| S009 | 1992-06-29 | Panel Track |
| S008 | 1991-12-16 | Normal 180 Day Track |
| S007 | 1991-07-01 | Normal 180 Day Track |
| S006 | 1990-10-02 | Normal 180 Day Track |
| S005 | 1990-02-07 | Normal 180 Day Track |
| S004 | 1989-03-27 | Normal 180 Day Track |
| S003 | 1989-03-02 | Normal 180 Day Track |
| S002 | 1987-02-24 | Normal 180 Day Track |
| S001 | 1987-02-24 | Normal 180 Day Track |