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.
| Device | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems |
| Generic Name | P2psa |
| Applicant | BECKMAN COULTER, INC.1000 Lake Hazeltine Dr.chaska, MN 55318 PMA NumberP090026 Supplement NumberS031 Date Received04/19/2021 Decision Date12/16/2022 Product Code OYA Advisory Committee Immunology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2021-04-19 |
| Decision Date | 2022-12-16 |
| PMA | P090026 |
| Supplement | S031 |
| 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 PMA NumberP090026 Supplement NumberS031 Date Received04/19/2021 Decision Date12/16/2022 Product Code OYA Advisory Committee Immunology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement a Modification To The UniCel DxI Immunoassay System’s Sample Probe And Reagent Probe Wash Nozzle Design Using Injection Molding To Reduce Production Cost |
| 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) |