ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Kit, Test, Alpha-fetoprotein For Neural Tube Defects

FDA Premarket Approval P980041 S021

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

Change to the special clean maintenance procedure that mitigates vitamin b 12 carryover from a wash buffer/ methanol combination to a methanol/di combination and also to use ethanol and methanol interchangeably as part of the special clean maintenance procedure. This special clean procedure would be used with the access afp, hybritech free psa,hybritech psa and hybritech p2psa reagents on the access, access 2, synchron lxi 725, and unicel dxc 600i integrated clinical systems.

DeviceACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Classification NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantBECKMAN COULTER, INC.
Date Received2013-01-03
Decision Date2013-02-06
PMAP980041
SupplementS021
Product CodeLOK
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
S043
S042
S041 2018-09-25 Real-time Process
S040 2018-08-13 30-day Notice
S039 2017-09-28 30-day Notice
S038
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
S020
S019
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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