therascreen KRAS RGQ PCR Kit

FDA Premarket Approval P110027 S015

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 NumberS015 Date Received06/15/2022 Decision Date07/11/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-15
Decision Date2022-07-11
PMAP110027
SupplementS015
Product CodeOWD 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressQIAGEN GmbH
qiagen Strasse 1
hilden 40724 PMA NumberP110027 Supplement NumberS015 Date Received06/15/2022 Decision Date07/11/2022 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  
Addition Of A Calibration Step For Manufacturing Internal Control

Supplemental Filings

Supplement NumberDateSupplement Type
P110027Original Filing
S015 2022-06-15 30-day Notice
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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