Roche Molecular System Inc 4300 Hacienda Drivepleasanton Ca 94588 Pma Numberp200014 Supplement Numbers004 Date Received10 18 2022 Decision Date11 29 2022 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 Roche Molecular System Inc 4300 Hacienda Drivepleasanton Ca 94588 Pma Numberp200014 Supplement Numbers004 Date Received10 18 2022 Decision Date11 29 2022 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 P200014S004 Roche Molecular System, Inc.4300 Hacienda Drivepleasanton, CA 94588 PMA NumberP200014 Supplement NumberS004 Date Received10/18/2022 Decision Date11/29/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	cobas® EZH2 Mutation Test	2022-11-29