Abbott Molecular1300 East Touhy Avenuedes Plaines Il 60018 Pma Numberp160044 Supplement Numbers004 Date Received05 19 2022 Decision Date06 09 2022 Product Code Pab 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 Molecular1300 East Touhy Avenuedes Plaines Il 60018 Pma Numberp160044 Supplement Numbers004 Date Received05 19 2022 Decision Date06 09 2022 Product Code Pab 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 P160044S004 ABBOTT MOLECULAR1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP160044 Supplement NumberS004 Date Received05/19/2022 Decision Date06/09/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali	2022-06-09