Qiagen 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

FDA Filings

This page includes the latest FDA filings for Qiagen 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. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P110027S015 QIAGEN 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	therascreen KRAS RGQ PCR Kit	2022-07-11