therascreen FGFR RGQ PCR Kit

FDA Premarket Approval P180043 S002

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

Changes to in-process qc testing

• Device: therascreen FGFR RGQ PCR Kit
• Generic Name: Somatic Gene Mutation Detection System
• Applicant: QIAGEN GmbH
• Date Received: 2020-03-04
• Decision Date: 2020-04-03
• PMA: P180043
• Supplement: S002
• Product Code: OWD
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: QIAGEN GmbH qiagen Strasse 1 hilden

Supplemental Filings

Supplement Number	Date	Supplement Type
P180043		Original Filing
S003	2021-09-20	Real-time Process
S002	2020-03-04	30-day Notice
S001

NIH GUDID Devices

Device ID	PMA	Supp
04053228034094	P180043	000
04053228043560	P180043	001