Roche Diagnostics Corp 9115 Hague Rd Indianapolis In 46250 Pma Numberp100032 Supplement Numbers021 Date Received09 30 2021 Decision Date04 04 2022 Product Code Lom Advisory Committee Microbiology Supplement Typenormal 180 Day Track 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 Numberp100032 Supplement Numbers021 Date Received09 30 2021 Decision Date04 04 2022 Product Code Lom Advisory Committee Microbiology Supplement Typenormal 180 Day Track 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 Registration(s)

FDA Filings

Device
Company
DeviceDate
ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP100032 Supplement NumberS021 Date Received09/30/2021 Decision Date04/04/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
 Elecsys Anti-HBc II2022-04-04

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