Access Hybritech PSA Reagents on the Access Immunoassay Systems

FDA Premarket Approval P850048 S053

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 modification to the unicel dxi immunoassay system’s pick and place gantries.

DeviceAccess Hybritech PSA Reagents on the Access Immunoassay Systems
Generic NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
ApplicantBECKMAN COULTER, INC.
Date Received2019-12-18
Decision Date2020-03-17
PMAP850048
SupplementS053
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
S053 2019-12-18 Real-time Process
S052 2019-05-13 Real-time Process
S051 2019-05-02 Real-time Process
S050
S049 2018-09-25 Real-time Process
S048 2017-09-28 30-day Notice
S047
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
S030
S029
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)
S010
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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