Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

FDA Premarket Approval P090026 S027

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 p2PSA Reagents on the Access Immunoassay Systems
Generic NameP2psa
ApplicantBECKMAN COULTER, INC.
Date Received2019-12-18
Decision Date2020-03-17
PMAP090026
SupplementS027
Product CodeOYA 
Advisory CommitteeImmunology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address BECKMAN COULTER, INC. 1000 Lake Hazeltine Dr. chaska, MN 55318

Supplemental Filings

Supplement NumberDateSupplement Type
P090026Original Filing
S027 2019-12-18 Real-time Process
S026 2019-05-13 Real-time Process
S025 2019-05-02 Real-time Process
S024
S023 2018-12-17 30-day Notice
S022 2018-09-25 Real-time Process
S021 2017-09-28 30-day Notice
S020
S019 2017-06-09 30-day Notice
S018 2017-03-22 Real-time Process
S017 2017-01-23 30-day Notice
S016 2017-01-17 30-day Notice
S015 2015-05-07 Real-time Process
S014 2014-11-04 135 Review Track For 30-day Notice
S013 2014-08-25 Real-time Process
S012 2014-08-25 135 Review Track For 30-day Notice
S011 2014-06-12 30-day Notice
S010 2013-12-17 Real-time Process
S009 2013-09-26 Special (immediate Track)
S008 2013-06-13 Special (immediate Track)
S007 2013-04-12 Special (immediate Track)
S006 2013-03-29 Real-time Process
S005 2013-01-23 Real-time Process
S004 2013-01-03 30-day Notice
S003
S002
S001 2012-10-25 Special (immediate Track)

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