Access Hybritech PSA Reagents on the Access Immunoassay Systems

FDA Premarket Approval P850048 S056

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 Hybritech PSA Reagents on the Access Immunoassay Systems
Generic NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
Date Received2020-09-30
Decision Date2020-12-16
Product CodeMTF 
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
P850048Original Filing
S056 2020-09-30 Real-time Process
S055 2020-07-22 Real-time Process
S054 2020-06-23 Real-time Process
S053 2019-12-18 Real-time Process
S052 2019-05-13 Real-time Process
S051 2019-05-02 Real-time Process
S049 2018-09-25 Real-time Process
S048 2017-09-28 30-day Notice
S046 2017-06-09 30-day Notice
S045 2017-03-22 Real-time Process
S044 2017-01-17 30-day Notice
S043 2016-10-11 30-day Notice
S042 2016-07-28 30-day Notice
S041 2015-05-07 Real-time Process
S040 2014-11-04 135 Review Track For 30-day Notice
S039 2014-08-25 Real-time Process
S038 2014-08-25 135 Review Track For 30-day Notice
S037 2013-12-17 Real-time Process
S036 2013-09-26 Special (immediate Track)
S035 2013-06-13 Special (immediate Track)
S034 2013-04-12 Special (immediate Track)
S033 2013-03-29 Real-time Process
S032 2013-01-23 Real-time Process
S031 2013-01-03 30-day Notice
S028 2012-10-25 Special (immediate Track)
S027 2012-03-15 Special (immediate Track)
S026 2011-12-23 Real-time Process
S025 2011-01-12 Special (immediate Track)
S024 2011-01-10 Special (immediate Track)
S023 2007-12-19 Real-time Process
S022 2007-05-16 Normal 180 Day Track
S021 2007-08-21 Panel Track
S020 2006-04-10 Real-time Process
S019 2002-12-20 Real-time Process
S018 2002-10-04 Real-time Process
S017 2002-08-19 Normal 180 Day Track
S016 1999-10-18 Normal 180 Day Track
S015 1999-07-12 30-day Notice
S014 1999-05-19 Normal 180 Day Track
S013 1999-04-27 Normal 180 Day Track
S012 1995-10-27 Normal 180 Day Track
S011 1995-06-14 Special (immediate Track)
S009 1992-06-29 Panel Track
S008 1991-12-16 Normal 180 Day Track
S007 1991-07-01 Normal 180 Day Track
S006 1990-10-02 Normal 180 Day Track
S005 1990-02-07 Normal 180 Day Track
S004 1989-03-27 Normal 180 Day Track
S003 1989-03-02 Normal 180 Day Track
S002 1987-02-24 Normal 180 Day Track
S001 1987-02-24 Normal 180 Day Track

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