therascreen KRAS RGQ PCR Kit

FDA Premarket Approval P110027 S014

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

Devicetherascreen KRAS RGQ PCR Kit
Generic NameSomatic Gene Mutation Detection System
ApplicantQIAGEN GmbHqiagen Strasse 1hilden 40724 PMA NumberP110027 Supplement NumberS014 Date Received05/19/2022 Decision Date06/17/2022 Product Code OWD  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-05-19
Decision Date2022-06-17
PMAP110027
SupplementS014
Product CodeOWD 
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressQIAGEN GmbH
qiagen Strasse 1
hilden 40724 PMA NumberP110027 Supplement NumberS014 Date Received05/19/2022 Decision Date06/17/2022 Product Code OWD  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For Changes To The Instructions For Use (IFU) To Strengthen Information In Relation To Interpretation Of Results For NSCLC Patients To Enhance The Safety Of The QIAGEN Therascreen KRAS RGQ PCR Kit.

Supplemental Filings

Supplement NumberDateSupplement Type
P110027Original Filing
S014 2022-05-19 Special (immediate Track)
S013
S012 2021-02-10 Panel Track
S011 2020-03-04 30-day Notice
S010 2018-03-08 30-day Notice
S009 2015-08-18 Normal 180 Day Track No User Fee
S008 2015-02-18 Normal 180 Day Track
S007 2015-01-26 Real-time Process
S006 2015-01-26 Real-time Process
S005 2015-01-21 30-day Notice
S004 2015-01-21 30-day Notice
S003 2014-12-22 30-day Notice
S002 2014-12-15 30-day Notice
S001

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