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 the addition of one fda-cleared tosoh automated immunoassay analyzer, the aia-900, for use with the st aia-pack pa assay.
| Device | IMMUNOASAY, 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 | 2011-03-30 |
| Decision Date | 2012-02-13 |
| PMA | P910065 |
| Supplement | S008 |
| Product Code | MTF |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |