ETI-CORE-IGMK PLUS assay

FDA Premarket Approval P990044 S029

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.

Pre-market Approval Supplement Details

To subcontract manufacturing equipment cleaning processes

DeviceETI-CORE-IGMK PLUS assay
ApplicantDIASORIN, INC.
Date Received2021-11-23
Decision Date2021-12-21
PMAP990044
SupplementS029
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DIASORIN, INC. 1951 Northwestern Ave. stillwater, MN 55082-0285

Supplemental Filings

Supplement NumberDateSupplement Type
P990044Original 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

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