COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

FDA Premarket Approval P110020 S011

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 to discontinue chemical testing for potassium concentration in mastermixes.

DeviceCOBAS 4800 BRAF V600 MUTATION TEST
Classification NameSomatic Gene Mutation Detection System
Generic NameSomatic Gene Mutation Detection System
ApplicantRoche Molecular Systems, Inc.
Date Received2013-12-13
Decision Date2014-01-09
PMAP110020
SupplementS011
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
P110020Original Filing
S037 2022-10-21 30-day Notice
S036
S035 2020-07-27 30-day Notice
S034 2019-09-20 30-day Notice
S033 2019-06-27 Real-time Process
S032 2019-04-24 30-day Notice
S031 2018-11-13 30-day Notice
S030 2018-11-09 30-day Notice
S029 2018-08-21 30-day Notice
S028 2018-07-27 30-day Notice
S027 2018-06-29 30-day Notice
S026 2018-06-08 30-day Notice
S025 2018-06-04 30-day Notice
S024 2018-03-01 30-day Notice
S023 2017-10-30 30-day Notice
S022 2017-09-26 30-day Notice
S021 2017-07-17 30-day Notice
S020 2017-07-14 30-day Notice
S019 2017-07-14 30-day Notice
S018 2016-08-22 30-day Notice
S017 2016-07-08 30-day Notice
S016 2016-06-30 Normal 180 Day Track
S015 2016-04-18 30-day Notice
S014 2015-06-24 30-day Notice
S013 2015-03-13 30-day Notice
S012 2014-12-19 30-day Notice
S011 2013-12-13 30-day Notice
S010 2013-12-13 Real-time Process
S009 2013-08-14 30-day Notice
S008 2013-08-09 30-day Notice
S007 2013-07-26 30-day Notice
S006 2012-09-12 Normal 180 Day Track
S005 2012-08-15 30-day Notice
S004 2012-07-02 Real-time Process
S003 2011-12-12 135 Review Track For 30-day Notice
S002 2011-09-29 30-day Notice
S001 2011-09-19 30-day Notice

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