This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | AIA-PACK PSA |
| Classification Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Generic Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Applicant | TOSOH BIOSCIENCE, INC. |
| Date Received | 1991-11-13 |
| Decision Date | 1993-07-07 |
| Notice Date | 1993-08-10 |
| PMA | P910065 |
| Supplement | S |
| Product Code | MTF |
| Docket Number | 93M-0251 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TOSOH BIOSCIENCE, INC. 6000 Shoreline Court suite 101 south San Francisco, CA 94080 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910065 | Original Filing | |
| S009 | 2019-05-20 | Special (immediate Track) |
| S008 | 2011-03-30 | Normal 180 Day Track |
| S007 | 2009-04-24 | Normal 180 Day Track |
| S006 | 2005-06-06 | Normal 180 Day Track |
| S005 | 2004-04-07 | Normal 180 Day Track |
| S004 | 2003-06-04 | Normal 180 Day Track |
| S003 | 2002-01-09 | Normal 180 Day Track |
| S002 | 1999-12-16 | Normal 180 Day Track |
| S001 | 1999-03-25 | Panel Track |