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.
Approval for labeling changes to align with globally harmonizedsystem of classification of chemicals (ghs) which provides a consistent hazard classification system that is recognized globally.
| Device | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
| Classification Name | P2psa |
| Generic Name | P2psa |
| Applicant | BECKMAN COULTER, INC. |
| Date Received | 2015-05-07 |
| Decision Date | 2015-06-23 |
| PMA | P090026 |
| Supplement | S015 |
| Product Code | OYA |
| Advisory Committee | Immunology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BECKMAN COULTER, INC. 1000 Lake Hazeltine Dr. chaska, MN 55318 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090026 | Original Filing | |
| S031 | 2021-04-19 | Real-time Process |
| S030 | 2020-09-30 | Real-time Process |
| S029 | 2020-07-22 | Real-time Process |
| S028 | 2020-06-23 | Real-time Process |
| S027 | 2019-12-18 | Real-time Process |
| S026 | 2019-05-13 | Real-time Process |
| S025 | 2019-05-02 | Real-time Process |
| S024 | ||
| S023 | 2018-12-17 | 30-day Notice |
| S022 | 2018-09-25 | Real-time Process |
| S021 | 2017-09-28 | 30-day Notice |
| S020 | ||
| S019 | 2017-06-09 | 30-day Notice |
| S018 | 2017-03-22 | Real-time Process |
| S017 | 2017-01-23 | 30-day Notice |
| S016 | 2017-01-17 | 30-day Notice |
| S015 | 2015-05-07 | Real-time Process |
| S014 | 2014-11-04 | 135 Review Track For 30-day Notice |
| S013 | 2014-08-25 | Real-time Process |
| S012 | 2014-08-25 | 135 Review Track For 30-day Notice |
| S011 | 2014-06-12 | 30-day Notice |
| S010 | 2013-12-17 | Real-time Process |
| S009 | 2013-09-26 | Special (immediate Track) |
| S008 | 2013-06-13 | Special (immediate Track) |
| S007 | 2013-04-12 | Special (immediate Track) |
| S006 | 2013-03-29 | Real-time Process |
| S005 | 2013-01-23 | Real-time Process |
| S004 | 2013-01-03 | 30-day Notice |
| S003 | ||
| S002 | ||
| S001 | 2012-10-25 | Special (immediate Track) |