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

FDA Filings

This page includes the latest FDA filings for 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. 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 P160041S035 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	cobas CMV	2022-12-14