D O Bio

FDA Filings

This page includes the latest FDA filings for D O Bio. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
New CleanFlex D.O Bio	Otc Medication	2021-12-25
NDC 81463-0002 D.O Bio	New CleanFlex	2021-12-24
CleanFlex D.O Bio	Otc Medication	2021-01-27
NDC 81463-0001 D.O Bio	CleanFlex	2021-01-26

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• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS008 Date Received09/21/2022 Decision Date12/21/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS022 Date Received11/10/2022 Decision Date12/08/2022 Product Code NCD  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS010 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS013 Date Received11/10/2022 Decision Date12/08/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS014 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS018 Date Received07/15/2022 Decision Date08/11/2022 Product Code NCD  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS017 Date Received04/13/2022 Decision Date07/08/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS016 Date Received04/05/2022 Decision Date06/23/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS012 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS006 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS011 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS010 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS015 Date Received04/05/2022 Decision Date05/06/2022 Product Code NCD  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS005 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS011 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS014 Date Received02/04/2022 Decision Date05/05/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS009 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS004 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS010 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
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