Manufacturing change to update a specification to allow for a limited amount of flash local to the gate location (where plastic material is injected into the reaction vessel) for the access 2 reaction vessels, which are used during the processing of the assays.
| Device | Access Hybritech Free PSA Reagents on the Access Immunoassay 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 | 2017-06-09 |
| Decision Date | 2017-07-07 |
| PMA | P970038 |
| Supplement | S034 |
| Product Code | MTG |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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