Pproval for 1) the change in polypropylene resin used for thereaction vessel container material that is used as the container for the reaction in the determination of results for access afp reagents, access hybritech psa reagents, access hybritech free psa reagents and access hybritech p2psa reagents; 2) the change inpolypropylene resin used for the reagent pack container for access hybritech p2psa reagents and 3) the change in polypropylene resin used for the bottle cap for access afp sample diluent and access hybritech psa sample diluent and access substrate for access afp, access hybritech psa, access hybritech free psa and access hybritech p2psa.
| 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 | 2013-01-23 |
| Decision Date | 2013-03-26 |
| PMA | P970038 |
| Supplement | S021 |
| 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