Approval for the access psa reagents for use on the unicel dxc 600i synchron access clinical system. The device, as modified, will be marketed under the trade name access free psa reagent on the access immunoassay system.
| Device | ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMUNOASSAY SYSTEMS |
| Classification Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | BECKMAN COULTER, INC. |
| Date Received | 2006-04-10 |
| Decision Date | 2006-05-18 |
| PMA | P970038 |
| Supplement | S008 |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices