cobas KRAS Mutation Test

Somatic Gene Mutation Detection System

FDA Premarket Approval P140023 S009

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

Relocation of manufacturing activities related to production of critical components.

Devicecobas KRAS Mutation Test
Classification NameSomatic Gene Mutation Detection System
Generic NameSomatic Gene Mutation Detection System
ApplicantRoche Molecular Systems, Inc.
Date Received2017-07-14
Decision Date2017-08-09
PMAP140023
SupplementS009
Product CodeOWD
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722

Supplemental Filings

Supplement NumberDateSupplement Type
P140023Original Filing
S025 2022-10-21 30-day Notice
S024
S023 2020-07-27 30-day Notice
S022 2020-02-18 Real-time Process
S021 2019-09-20 30-day Notice
S020 2019-04-24 30-day Notice
S019 2018-11-13 30-day Notice
S018 2018-11-09 30-day Notice
S017 2018-08-21 30-day Notice
S016 2018-07-27 30-day Notice
S015 2018-06-08 30-day Notice
S014 2018-06-04 30-day Notice
S013 2018-03-01 30-day Notice
S012 2017-10-30 30-day Notice
S011 2017-09-27 30-day Notice
S010 2017-07-17 30-day Notice
S009 2017-07-14 30-day Notice
S008 2016-09-22 30-day Notice
S007 2016-08-22 30-day Notice
S006 2016-07-08 30-day Notice
S005 2016-04-18 30-day Notice
S004 2016-02-29 Normal 180 Day Track
S003 2016-01-28 Real-time Process
S002 2015-09-02 30-day Notice
S001 2015-06-24 30-day Notice

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