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 adding a quality assurance inspection step.
Device | BIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY |
Classification Name | Assay,enzyme Linked Immunosorbent,parvovirus B19 Igg |
Generic Name | Assay,enzyme Linked Immunosorbent,parvovirus B19 Igg |
Applicant | DIASORIN |
Date Received | 2002-11-15 |
Decision Date | 2003-01-09 |
PMA | P970054 |
Supplement | S001 |
Product Code | MYL |
Advisory Committee | Microbiology |
Supplement Type | Special (immediate Track) |
Expedited Review | No |
Combination Product | No |
Applicant Address | DIASORIN 1951 Northwestern Avenue stillwater, MN 55082-0285 |
Supplement Number | Date | Supplement Type |
---|---|---|
P970054 | Original Filing | |
S020 | 2021-11-23 | 30-day Notice |
S019 | 2020-07-16 | 30-day Notice |
S018 | 2020-03-30 | 30-day Notice |
S017 | ||
S016 | ||
S015 | 2018-08-08 | Normal 180 Day Track No User Fee |
S014 | ||
S013 | 2017-02-08 | 30-day Notice |
S012 | 2016-12-22 | 30-day Notice |
S011 | 2016-02-02 | 30-day Notice |
S010 | 2013-11-27 | 30-day Notice |
S009 | 2011-06-24 | Normal 180 Day Track No User Fee |
S008 | 2010-02-17 | 30-day Notice |
S007 | 2009-02-09 | 30-day Notice |
S006 | 2007-07-31 | 30-day Notice |
S005 | 2007-06-04 | 135 Review Track For 30-day Notice |
S004 | 2007-05-14 | 30-day Notice |
S003 | ||
S002 | 2005-03-23 | 30-day Notice |
S001 | 2002-11-15 | Special (immediate Track) |