PATHWAY ANTI-C-KIT PRIMARY ANTIBODY

FDA Premarket Approval P020055 S001

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

Change of system operating software from dos to windows for the drop volume tester computer workstation hardware.

DevicePATHWAY ANTI-C-KIT PRIMARY ANTIBODY
Generic NameImmunohistochemistry Antibody Assay, C-kit
ApplicantVENTANA MEDICAL SYSTEMS, INC.
Date Received2007-04-16
Decision Date2007-05-16
PMAP020055
SupplementS001
Product CodeNKF 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P020055Original Filing
S028 2022-10-14 30-day Notice
S027 2022-07-12 30-day Notice
S026 2022-02-16 Special (immediate Track)
S025 2022-01-28 135 Review Track For 30-day Notice
S024 2021-02-22 Real-time Process
S023 2020-08-26 Real-time Process
S022 2020-01-13 Real-time Process
S021
S020 2017-07-17 30-day Notice
S019 2016-11-15 Normal 180 Day Track
S018 2015-12-10 135 Review Track For 30-day Notice
S017 2015-08-26 30-day Notice
S016 2014-10-27 30-day Notice
S015 2014-06-16 135 Review Track For 30-day Notice
S014 2014-02-06 Real-time Process
S013 2014-01-06 30-day Notice
S012 2013-11-12 30-day Notice
S011 2013-10-28 30-day Notice
S010 2013-10-11 Normal 180 Day Track
S009 2013-08-30 30-day Notice
S008 2013-05-06 Real-time Process
S007 2013-04-17 30-day Notice
S006 2013-03-04 30-day Notice
S005 2012-12-11 Real-time Process
S004 2012-08-31 Real-time Process
S003 2012-06-26 30-day Notice
S002 2011-05-23 Normal 180 Day Track
S001 2007-04-16 30-day Notice

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