Abbott Diabetes Care

FDA Filings

This page includes the latest FDA filings for Abbott Diabetes Care. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device Company	Device	Date
PMN K130094 ABBOTT DIABETES CARE	FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM	2013-06-27

Similar & Related FDA Registered Companies

Abbott Diabetes Care Inc.
ABBOTT DIABETES CARE INC.1360 South Loop Dr.alameda, CA 94502-7000 PMA NumberP160030 Supplement NumberS052 Date Received12/19/2022 Decision Date01/17/2023 Product Code PZE Advisory Committee Clinical Chemistry Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Abbott Diabetes Care Inc.1360 South Loop Rd.alameda, CA 94502 PMA NumberP150021 Supplement NumberS057 Date Received04/01/2022 Decision Date04/28/2022 Product Code MDS Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ABBOTT DIABETES CARE INC.1360 South Loop Dr.alameda, CA 94502-7000 PMA NumberP160030 Supplement NumberS051 Date Received04/01/2022 Decision Date04/28/2022 Product Code PZE Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ABBOTT DIABETES CARE INC.1360 South Loop Dr.alameda, CA 94502-7000 PMA NumberP160030 Supplement NumberS050 Date Received02/18/2022 Decision Date03/16/2022 Product Code PZE Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Abbott Diabetes Care Inc.1360 South Loop Rd.alameda, CA 94502 PMA NumberP150021 Supplement NumberS056 Date Received02/18/2022 Decision Date03/16/2022 Product Code MDS Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ABBOTT DIABETES CARE INC.1360 South Loop Dr.alameda, CA 94502-7000 PMA NumberP160030 Supplement NumberS049 Date Received02/01/2022 Decision Date03/02/2022 Product Code PZE Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Abbott Diabetes Care Inc.1360 South Loop Rd.alameda, CA 94502 PMA NumberP150021 Supplement NumberS055 Date Received02/01/2022 Decision Date03/02/2022 Product Code MDS Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ABBOTT DIABETES CARE LTD

Related Finance Registrations

NCAGE Code	U01E4	ABBOTT DIABETES CARE
CAGE Code	U01E4	ABBOTT DIABETES CARE
DUNS	794274311	ABBOTT DIABETES CARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092164730	Liverpool,United Kingdom -> Norfolk, Virginia	DIABETIC TEST STRIPS	39 PCS
2020091658839	Liverpool,United Kingdom -> Norfolk, Virginia	DIABETIC TEST STRIPS NON HAZ	40 PCS
2020090762327	Liverpool,United Kingdom -> Norfolk, Virginia	DIABETIC TEST STRIPS NON HAZ	39 PCS
2020090180981	Liverpool,United Kingdom -> Norfolk, Virginia	DIABETIC TEST STRIPS NON HAZ	40 PCS
2020081870565	Liverpool,United Kingdom -> Norfolk, Virginia	DIABETIC TEST STRIPS	39 PCS
2020081063613	Liverpool,United Kingdom -> Norfolk, Virginia	DIABETIC TEST STRIPS NON HAZ	39 PCS
2020080361511	Liverpool,United Kingdom -> Norfolk, Virginia	DIABETIC TEST STRIPS	39 PCS
2020072859498	Liverpool,United Kingdom -> Norfolk, Virginia	DIABETIC TEST STRIPS	40 PCS