Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

P2psa

FDA Premarket Approval P090026 S019

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

Manufacturing change to update a specification to allow for a limited amount of flash local to the gate location (where plastic material is injected into the reaction vessel) for the access 2 reaction vessels, which are used during the processing of the assays.

DeviceAccess Hybritech p2PSA Reagents on the Access Immunoassay Systems
Classification NameP2psa
Generic NameP2psa
ApplicantBECKMAN COULTER, INC.
Date Received2017-06-09
Decision Date2017-07-07
PMAP090026
SupplementS019
Product CodeOYA
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BECKMAN COULTER, INC. 1000 Lake Hazeltine Dr. chaska, MN 55318

Supplemental Filings

Supplement NumberDateSupplement Type
P090026Original Filing
S031 2021-04-19 Real-time Process
S030 2020-09-30 Real-time Process
S029 2020-07-22 Real-time Process
S028 2020-06-23 Real-time Process
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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