Access AFP Reagents on the Access Immunoassay Systems

FDA Premarket Approval P980041 S049

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

Approval for a modification to connect the unicel dxi immunoassay systems to the dxa 5000 automation system

DeviceAccess AFP Reagents on the Access Immunoassay Systems
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
Date Received2020-09-30
Decision Date2020-12-16
Product CodeLOK 
Advisory CommitteeImmunology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address BECKMAN COULTER, INC. 250 South Kraemer Blvd M/s w-110 brea, CA 92822

Supplemental Filings

Supplement NumberDateSupplement Type
P980041Original Filing
S049 2020-09-30 Real-time Process
S048 2020-07-22 Real-time Process
S047 2020-06-23 Real-time Process
S046 2019-12-18 Real-time Process
S045 2019-05-13 Real-time Process
S044 2019-05-02 Real-time Process
S041 2018-09-25 Real-time Process
S040 2018-08-13 30-day Notice
S039 2017-09-28 30-day Notice
S037 2017-06-09 30-day Notice
S036 2017-03-22 Real-time Process
S035 2017-01-17 30-day Notice
S034 2016-06-10 135 Review Track For 30-day Notice
S033 2015-06-05 30-day Notice
S032 2015-05-07 Real-time Process
S031 2014-11-10 30-day Notice
S030 2014-11-04 135 Review Track For 30-day Notice
S029 2014-08-25 Real-time Process
S028 2014-08-25 135 Review Track For 30-day Notice
S027 2013-12-17 Real-time Process
S026 2013-09-26 Special (immediate Track)
S025 2013-06-13 Special (immediate Track)
S024 2013-04-12 Special (immediate Track)
S023 2013-03-29 Real-time Process
S022 2013-01-23 Real-time Process
S021 2013-01-03 30-day Notice
S018 2012-10-25 Special (immediate Track)
S017 2012-03-15 Special (immediate Track)
S016 2011-12-23 Real-time Process
S015 2011-01-12 Special (immediate Track)
S014 2011-01-10 Special (immediate Track)
S013 2010-09-27 Normal 180 Day Track
S012 2008-05-27 Real-time Process
S011 2008-02-26 Special (immediate Track)
S010 2007-09-07 Real-time Process
S009 2007-05-30 Normal 180 Day Track
S008 2006-04-10 Real-time Process
S007 2006-01-18 30-day Notice
S006 2004-07-29 Real-time Process
S005 2004-07-01 30-day Notice
S004 2003-12-02 Normal 180 Day Track No User Fee
S003 2002-12-04 Real-time Process
S002 2002-07-22 Normal 180 Day Track
S001 2002-06-18 Normal 180 Day Track

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