Abbott Laboratories100 Abbott Park Rd Dept 09v6 Bldg Ap5 2abbott Park Il 60064 6088 Pma Numberp110029 Supplement Numbers039 Date Received09 14 2022 Decision Date10 12 2022 Product Code Lom Advisory Committee Microbiology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Abbott Laboratories100 Abbott Park Rd Dept 09v6 Bldg Ap5 2abbott Park Il 60064 6088 Pma Numberp110029 Supplement Numbers039 Date Received09 14 2022 Decision Date10 12 2022 Product Code Lom Advisory Committee Microbiology Supplement Type30 Day Notice 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 P110029S039 Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS039 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory	2022-10-12