therascreen EGFR RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Premarket Approval P120022 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

Change the supplier and the polymer used for a kit consumable.

Devicetherascreen EGFR RGQ PCR Kit
Classification NameSomatic Gene Mutation Detection System
Generic NameSomatic Gene Mutation Detection System
ApplicantQIAGEN MANCHESTER LTD
Date Received2018-03-08
Decision Date2018-04-06
PMAP120022
SupplementS019
Product CodeOWD
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address QIAGEN MANCHESTER LTD skelton House lloyd Street North manchester M15 6

Supplemental Filings

Supplement NumberDateSupplement Type
P120022Original Filing
S022 2020-10-23 Real-time Process
S021 2020-03-04 30-day Notice
S020 2019-08-28 Special (immediate Track)
S019 2018-03-08 30-day Notice
S018 2018-02-16 Normal 180 Day Track
S017 2018-01-26 30-day Notice
S016 2017-07-28 Normal 180 Day Track
S015 2017-06-29 30-day Notice
S014 2016-12-28 Normal 180 Day Track
S013 2016-08-10 30-day Notice
S012 2015-09-28 Normal 180 Day Track No User Fee
S011
S010 2015-02-18 Normal 180 Day Track
S009 2015-01-26 Real-time Process
S008 2015-01-26 Real-time Process
S007 2015-01-21 30-day Notice
S006 2015-01-21 30-day Notice
S005 2014-12-22 30-day Notice
S004 2014-12-15 30-day Notice
S003
S002 2014-11-19 30-day Notice
S001 2014-09-18 Normal 180 Day Track

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