Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

FDA Premarket Approval P970038 S044

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 Free PSA Reagents on the Access Immunoassay Systems
Generic NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Date Received2020-09-30
Decision Date2020-12-16
Product CodeMTG 
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
P970038Original Filing
S044 2020-09-30 Real-time Process
S043 2020-07-22 Real-time Process
S042 2020-06-23 Real-time Process
S041 2019-12-18 Real-time Process
S040 2019-05-13 Real-time Process
S039 2019-05-02 Real-time Process
S037 2018-09-25 Real-time Process
S036 2017-09-28 30-day Notice
S034 2017-06-09 30-day Notice
S033 2017-03-22 Real-time Process
S032 2017-01-17 30-day Notice
S031 2015-05-07 Real-time Process
S030 2015-01-27 135 Review Track For 30-day Notice
S029 2014-11-04 135 Review Track For 30-day Notice
S028 2014-08-25 Real-time Process
S027 2014-08-25 135 Review Track For 30-day Notice
S026 2013-12-17 Real-time Process
S025 2013-09-26 Special (immediate Track)
S024 2013-06-13 Special (immediate Track)
S023 2013-04-12 Special (immediate Track)
S022 2013-03-29 Real-time Process
S021 2013-01-23 Real-time Process
S020 2013-01-03 30-day Notice
S017 2012-10-25 Special (immediate Track)
S016 2012-03-15 Special (immediate Track)
S015 2011-12-23 Real-time Process
S014 2011-01-12 Special (immediate Track)
S013 2011-01-10 Special (immediate Track)
S012 2008-05-27 Normal 180 Day Track
S011 2007-12-19 Real-time Process
S010 2007-05-14 30-day Notice
S009 2007-05-16 Normal 180 Day Track
S008 2006-04-10 Real-time Process
S007 2002-12-20 Real-time Process
S006 2002-10-07 Real-time Process
S005 2002-08-19 Normal 180 Day Track
S004 1999-08-27 Normal 180 Day Track
S003 1999-05-14 Normal 180 Day Track
S002 1999-04-27 Normal 180 Day Track
S001 1998-07-23 Normal 180 Day Track

© 2021
This site is not affiliated with or endorsed by the FDA.