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 Free PSA Reagents on the Access Immunoassay Systems |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | BECKMAN COULTER, INC.250 South Kraemer Blvd M/sw-110brea, CA 92822 PMA NumberP970038 Supplement NumberS045 Date Received04/19/2021 Decision Date12/16/2022 Product Code MTG 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 | P970038 |
| Supplement | S045 |
| Product Code | MTG |
| 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. 250 South Kraemer Blvd M/s w-110 brea, CA 92822 PMA NumberP970038 Supplement NumberS045 Date Received04/19/2021 Decision Date12/16/2022 Product Code MTG 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 |
|---|---|---|
| P970038 | Original Filing | |
| S045 | 2021-04-19 | Real-time Process |
| S044 | 2020-09-30 | Real-time Process |
| S043 | 2020-07-22 | Real-time Process |
| S042 | 2020-06-23 | Real-time Process |
| S041 | 2019-12-18 | Real-time Process |
| S040 | 2019-05-13 | Real-time Process |
| S039 | 2019-05-02 | Real-time Process |
| S038 | ||
| S037 | 2018-09-25 | Real-time Process |
| S036 | 2017-09-28 | 30-day Notice |
| S035 | ||
| S034 | 2017-06-09 | 30-day Notice |
| S033 | 2017-03-22 | Real-time Process |
| S032 | 2017-01-17 | 30-day Notice |
| S031 | 2015-05-07 | Real-time Process |
| S030 | 2015-01-27 | 135 Review Track For 30-day Notice |
| S029 | 2014-11-04 | 135 Review Track For 30-day Notice |
| S028 | 2014-08-25 | Real-time Process |
| S027 | 2014-08-25 | 135 Review Track For 30-day Notice |
| S026 | 2013-12-17 | Real-time Process |
| S025 | 2013-09-26 | Special (immediate Track) |
| S024 | 2013-06-13 | Special (immediate Track) |
| S023 | 2013-04-12 | Special (immediate Track) |
| S022 | 2013-03-29 | Real-time Process |
| S021 | 2013-01-23 | Real-time Process |
| S020 | 2013-01-03 | 30-day Notice |
| S019 | ||
| S018 | ||
| S017 | 2012-10-25 | Special (immediate Track) |
| S016 | 2012-03-15 | Special (immediate Track) |
| S015 | 2011-12-23 | Real-time Process |
| S014 | 2011-01-12 | Special (immediate Track) |
| S013 | 2011-01-10 | Special (immediate Track) |
| S012 | 2008-05-27 | Normal 180 Day Track |
| S011 | 2007-12-19 | Real-time Process |
| S010 | 2007-05-14 | 30-day Notice |
| S009 | 2007-05-16 | Normal 180 Day Track |
| S008 | 2006-04-10 | Real-time Process |
| S007 | 2002-12-20 | Real-time Process |
| S006 | 2002-10-07 | Real-time Process |
| S005 | 2002-08-19 | Normal 180 Day Track |
| S004 | 1999-08-27 | Normal 180 Day Track |
| S003 | 1999-05-14 | Normal 180 Day Track |
| S002 | 1999-04-27 | Normal 180 Day Track |
| S001 | 1998-07-23 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| H628372101 | P970038 | 004 |