Roche Molecular System Inc

FDA Filings

This page includes the latest FDA filings for Roche Molecular System Inc. 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 P200014S003 Roche Molecular System, Inc.	cobas® EZH2 Mutation Test	2021-08-10
PMA P200014S001 Roche Molecular System, Inc.	cobas® EZH2 Mutation Test	2020-08-26
PMA P200014 Roche Molecular System, Inc.	cobas® EZH2 Mutation Test	2020-06-18

Similar & Related FDA Registered Companies

• Roche Molecular Systems, Inc.
• ROCHE MOLECULAR SYSTEMS, INC.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP160041 Supplement NumberS035 Date Received05/31/2022 Decision Date12/14/2022 Product Code PAB  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• 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
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP110020 Supplement NumberS037 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
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP050028 Supplement NumberS086 Date Received10/21/2022 Decision Date11/14/2022 Product Code MKT  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP100020 Supplement NumberS054 Date Received10/21/2022 Decision Date11/14/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP110037 Supplement NumberS057 Date Received10/21/2022 Decision Date11/14/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP140023 Supplement NumberS025 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