ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay

FDA Premarket Approval P990038 S032

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-MAK-2 PLUS and HBsAg Confirmatory Test assay
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDIASORIN, INC.
Date Received2021-11-23
Decision Date2021-12-21
PMAP990038
SupplementS032
Product CodeLOM 
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
P990038Original Filing
S032 2021-11-23 30-day Notice
S031 2020-07-16 30-day Notice
S030 2019-08-28 30-day Notice
S029 2019-06-18 30-day Notice
S028 2018-05-30 30-day Notice
S027 2018-03-30 30-day Notice
S026
S025 2018-02-14 30-day Notice
S024 2017-09-18 30-day Notice
S023 2017-04-25 30-day Notice
S022 2017-03-29 30-day Notice
S021 2016-05-10 30-day Notice
S020 2014-06-05 30-day Notice
S019 2013-12-27 30-day Notice
S018 2013-06-05 30-day Notice
S017 2012-11-09 Special (immediate Track)
S016
S015 2012-02-17 30-day Notice
S014 2011-10-18 30-day Notice
S013 2009-11-13 135 Review Track For 30-day Notice
S012 2009-11-13 Real-time Process
S011 2006-03-24 Special (immediate Track)
S010 2005-06-03 30-day Notice
S009
S008 2004-04-23 30-day Notice
S007 2004-04-05 30-day Notice
S006 2004-04-05 30-day Notice
S005 2003-07-16 Special (immediate Track)
S004 2002-10-29 Normal 180 Day Track
S003 2002-10-17 30-day Notice
S002 2002-01-16 Normal 180 Day Track
S001

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