Abbott Laboratories100 Abbott Park Rd Dept 09v6 Bldg Ap5 2abbott Park Il 60064 6088 Pma Numberp110029 Supplement Numbers041 Date Received01 06 2023 Decision Date01 27 2023 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 Numbers041 Date Received01 06 2023 Decision Date01 27 2023 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 P110029S041 Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS041 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf	2023-01-27