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

FDA Filings

This page includes the latest FDA filings for 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. 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 P050028S086 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	COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0	2022-11-14