Roche4300 Hacienda Drivepo Box 9002pleasanton Ca 94588 Pma Numberp120019 Supplement Numbers034 Date Received10 21 2022 Decision Date11 14 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 Roche4300 Hacienda Drivepo Box 9002pleasanton Ca 94588 Pma Numberp120019 Supplement Numbers034 Date Received10 21 2022 Decision Date11 14 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 P120019S034 ROCHE4300 Hacienda Drivepo Box 9002pleasanton, CA 94588 PMA NumberP120019 Supplement NumberS034 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	cobas® EGFR Mutation Test, v2.0	2022-11-14