Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

FDA Premarket Approval P970038 S042

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

Modification to the access 2 immunoassay system pipettor gantry

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 Received2020-06-23
Decision Date2020-10-07
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
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

© 2020
This site is not affiliated with or endorsed by the FDA.