Roche Diagnostics Corp 9115 Hague Rd Indianapolis In 46250 Pma Numberp090008 Supplement Numbers023 Date Received09 30 2022 Decision Date01 24 2023 Reclassified Date 12 22 2021 Product Code Mzo Advisory Committee Microbiology Supplement Typereal Time Process Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Roche Diagnostics Corp 9115 Hague Rd Indianapolis In 46250 Pma Numberp090008 Supplement Numbers023 Date Received09 30 2022 Decision Date01 24 2023 Reclassified Date 12 22 2021 Product Code Mzo Advisory Committee Microbiology Supplement Typereal Time Process Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 P090008S023 ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP090008 Supplement NumberS023 Date Received09/30/2022 Decision Date01/24/2023 Reclassified Date 12/22/2021 Product Code MZO  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	VITROS HBeAg Assays	2023-01-24