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 a modification to the unicel dxl clinical system's reagent pipettor gantry and to the reagent vessel carriage by changing the carriage motor and carriage rail suppliers to simplify the design resulting in improvements to manufacturability, service and assembly and cost reduction.
| Device | Acess AFP Reagents on the Access Immunoassay Systems |
| Classification Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | BECKMAN COULTER, INC. |
| Date Received | 2018-09-25 |
| Decision Date | 2018-12-21 |
| PMA | P980041 |
| Supplement | S041 |
| Product Code | LOK |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980041 | Original Filing | |
| S049 | 2020-09-30 | Real-time Process |
| S048 | 2020-07-22 | Real-time Process |
| S047 | 2020-06-23 | Real-time Process |
| S046 | 2019-12-18 | Real-time Process |
| S045 | 2019-05-13 | Real-time Process |
| S044 | 2019-05-02 | Real-time Process |
| S043 | ||
| S042 | ||
| S041 | 2018-09-25 | Real-time Process |
| S040 | 2018-08-13 | 30-day Notice |
| S039 | 2017-09-28 | 30-day Notice |
| S038 | ||
| S037 | 2017-06-09 | 30-day Notice |
| S036 | 2017-03-22 | Real-time Process |
| S035 | 2017-01-17 | 30-day Notice |
| S034 | 2016-06-10 | 135 Review Track For 30-day Notice |
| S033 | 2015-06-05 | 30-day Notice |
| S032 | 2015-05-07 | Real-time Process |
| S031 | 2014-11-10 | 30-day Notice |
| S030 | 2014-11-04 | 135 Review Track For 30-day Notice |
| S029 | 2014-08-25 | Real-time Process |
| S028 | 2014-08-25 | 135 Review Track For 30-day Notice |
| S027 | 2013-12-17 | Real-time Process |
| S026 | 2013-09-26 | Special (immediate Track) |
| S025 | 2013-06-13 | Special (immediate Track) |
| S024 | 2013-04-12 | Special (immediate Track) |
| S023 | 2013-03-29 | Real-time Process |
| S022 | 2013-01-23 | Real-time Process |
| S021 | 2013-01-03 | 30-day Notice |
| S020 | ||
| S019 | ||
| S018 | 2012-10-25 | Special (immediate Track) |
| S017 | 2012-03-15 | Special (immediate Track) |
| S016 | 2011-12-23 | Real-time Process |
| S015 | 2011-01-12 | Special (immediate Track) |
| S014 | 2011-01-10 | Special (immediate Track) |
| S013 | 2010-09-27 | Normal 180 Day Track |
| S012 | 2008-05-27 | Real-time Process |
| S011 | 2008-02-26 | Special (immediate Track) |
| S010 | 2007-09-07 | Real-time Process |
| S009 | 2007-05-30 | Normal 180 Day Track |
| S008 | 2006-04-10 | Real-time Process |
| S007 | 2006-01-18 | 30-day Notice |
| S006 | 2004-07-29 | Real-time Process |
| S005 | 2004-07-01 | 30-day Notice |
| S004 | 2003-12-02 | Normal 180 Day Track No User Fee |
| S003 | 2002-12-04 | Real-time Process |
| S002 | 2002-07-22 | Normal 180 Day Track |
| S001 | 2002-06-18 | Normal 180 Day Track |