Abbott Diagnostics Scarborough Inc 10 Southgate Roadscarborough Me 04074 Pma Numberp940035 Supplement Numbers017 Date Received02 08 2022 Decision Date07 12 2022 Product Code Nah Advisory Committee Immunology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Abbott Diagnostics Scarborough Inc 10 Southgate Roadscarborough Me 04074 Pma Numberp940035 Supplement Numbers017 Date Received02 08 2022 Decision Date07 12 2022 Product Code Nah Advisory Committee Immunology Supplement Typenormal 180 Day Track No User Fee 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 P940035S017 Abbott Diagnostics Scarborough, Inc.10 Southgate Roadscarborough, ME 04074 PMA NumberP940035 Supplement NumberS017 Date Received02/08/2022 Decision Date07/12/2022 Product Code NAH  Advisory Committee Immunology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	NMP22 BladderCheck Test	2022-07-12