THERASCREEN KRAS RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Premarket Approval P110027 S008

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 the change in manufacturing of a critical reagent (taq polymerase) and the conversion of a manual reagent fill process to one that is automated.

DeviceTHERASCREEN KRAS RGQ PCR KIT
Classification NameSomatic Gene Mutation Detection System
Generic NameSomatic Gene Mutation Detection System
ApplicantQIAGEN MANCHESTER LTD
Date Received2015-02-18
Decision Date2015-08-06
PMAP110027
SupplementS008
Product CodeOWD
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address QIAGEN MANCHESTER LTD skelton House lloyd Street North manchester M15 6

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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