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.
Pproval for 1) the change in polypropylene resin used for thereaction vessel container material that is used as the container for the reaction in the determination of results for access afp reagents, access hybritech psa reagents, access hybritech free psa reagents and access hybritech p2psa reagents; 2) the change inpolypropylene resin used for the reagent pack container for access hybritech p2psa reagents and 3) the change in polypropylene resin used for the bottle cap for access afp sample diluent and access hybritech psa sample diluent and access substrate for access afp, access hybritech psa, access hybritech free psa and access hybritech p2psa.
| Device | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM |
| Classification Name | P2psa |
| Generic Name | P2psa |
| Applicant | BECKMAN COULTER, INC. |
| Date Received | 2013-01-23 |
| Decision Date | 2013-03-26 |
| PMA | P090026 |
| Supplement | S005 |
| Product Code | OYA |
| Advisory Committee | Immunology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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) |