cobas® KRAS Mutation Test

FDA Premarket Approval P140023 S025

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

Devicecobas® KRAS Mutation Test
Generic NameSomatic Gene Mutation Detection System
ApplicantRoche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP140023 Supplement NumberS025 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-21
Decision Date2022-11-14
PMAP140023
SupplementS025
Product CodeOWD 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressRoche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton, CA 94588-2722 PMA NumberP140023 Supplement NumberS025 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
removal Of An In-process Testing (IPT) From The Manufacturing Process

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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