Abbott Molecular Inc 1300 E Touhy Avenuedes Plaines Il 60018 Pma Numberp170005 Supplement Numbers004 Date Received03 10 2022 Decision Date04 11 2022 Product Code Owd Advisory Committee Supplement Typespecial Immediate Track Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Abbott Molecular Inc 1300 E Touhy Avenuedes Plaines Il 60018 Pma Numberp170005 Supplement Numbers004 Date Received03 10 2022 Decision Date04 11 2022 Product Code Owd Advisory Committee Supplement Typespecial Immediate Track 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 P170005S004 Abbott Molecular Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP170005 Supplement NumberS004 Date Received03/10/2022 Decision Date04/11/2022 Product Code OWD  Advisory Committee Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit	2022-04-11