therascreen EGFR RGQ PCR Kit

FDA Premarket Approval P120022 S022

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

Approval for incorporation of a lower boundary for the therascreen egfr rgq pcr assay ct cutoff range and an update to the software and handbook to address this change.

Devicetherascreen EGFR RGQ PCR Kit
Generic NameSomatic Gene Mutation Detection System
ApplicantQIAGEN GmbH
Date Received2020-10-23
Decision Date2021-07-07
PMAP120022
SupplementS022
Product CodeOWD 
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address QIAGEN GmbH qiagen Strasse 1 hilden 40724

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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