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.
Improve the process for cleaning critical manufacturing parts and equipment.
| Device | ETI-CORE-IGMK PLUS Assay |
| Classification Name | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Premarket Approval (PMA) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUr |
| Generic Name | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Premarket Approval (PMA) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUr |
| Applicant | DIASORIN, INC. |
| Date Received | 2018-03-30 |
| Decision Date | 2018-04-24 |
| PMA | P990044 |
| Supplement | S024 |
| Product Code | Premarket |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DIASORIN, INC. 1951 Northwestern Ave. stillwater, MN 55082-0285 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990044 | Original Filing | |
| S029 | 2021-11-23 | 30-day Notice |
| S028 | 2020-07-16 | 30-day Notice |
| S027 | 2019-08-28 | 30-day Notice |
| S026 | 2019-06-18 | 30-day Notice |
| S025 | 2018-05-30 | 30-day Notice |
| S024 | 2018-03-30 | 30-day Notice |
| S023 | ||
| S022 | 2018-02-14 | 30-day Notice |
| S021 | 2017-09-18 | 30-day Notice |
| S020 | 2017-04-25 | 30-day Notice |
| S019 | 2017-03-29 | 30-day Notice |
| S018 | 2016-05-10 | 30-day Notice |
| S017 | 2014-06-05 | 30-day Notice |
| S016 | 2013-12-27 | 30-day Notice |
| S015 | 2013-06-05 | 30-day Notice |
| S014 | 2012-11-09 | Special (immediate Track) |
| S013 | ||
| S012 | 2012-02-17 | 30-day Notice |
| S011 | 2011-10-18 | 30-day Notice |
| S010 | 2009-11-13 | 135 Review Track For 30-day Notice |
| S009 | 2009-11-13 | Real-time Process |
| S008 | 2006-12-29 | 30-day Notice |
| S007 | 2005-06-03 | 30-day Notice |
| S006 | ||
| S005 | 2004-04-05 | 30-day Notice |
| S004 | 2003-04-14 | 30-day Notice |
| S003 | 2003-04-09 | Normal 180 Day Track No User Fee |
| S002 | 2002-10-17 | 30-day Notice |
| S001 | 2002-01-07 | Normal 180 Day Track |