Abbott Molecular Inc 1300 East Touhy Avenuedes Plaines Il 60018 Pma Numberp170041 Supplement Numbers006 Date Received12 17 2021 Decision Date12 01 2022 Product Code Owd Advisory Committee Clinical Trialsnct02719574 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 Abbott Molecular Inc 1300 East Touhy Avenuedes Plaines Il 60018 Pma Numberp170041 Supplement Numbers006 Date Received12 17 2021 Decision Date12 01 2022 Product Code Owd Advisory Committee Clinical Trialsnct02719574 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 Filings

Device Company	Device	Date
PMA P170041S006 Abbott Molecular, Inc.1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP170041 Supplement NumberS006 Date Received12/17/2021 Decision Date12/01/2022 Product Code OWD  Advisory Committee Clinical TrialsNCT02719574 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime	2022-12-01