Abbott Ireland Diabetes Care

FDA Filings

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

FDA Registration(s)

• Registration Number: 3007031103
• FEI Number: 3007031103
• Name: Abbott Ireland Diabetes Care
• Owner & Operator: ABBOTT LABORATORIES
• Contact Address: 100 ABBOTT PARK RD. D-03Q3, AP52-1; Abbott Park IL 60064 US
• US Agent:
  • Arul Sterlin
  • Abbott Diabetes Care Inc.
  • 510 8644310
  • arul.sterlin@abbott.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Donegal Town, Co. Donegal ; Donegal Town Donegal, Donegal IE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K152328 | NBW Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle InsuLinx Blood Glucose Monitoring System	2015-11-01
PMN K152328 | LFR Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle InsuLinx Blood Glucose Monitoring System	2015-11-01
PMN K150531 | NBW Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Freedom Lite Blood Glucose Monitoring System	2015-11-01
PMN K150531 | LFR Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Freedom Lite Blood Glucose Monitoring System	2015-11-01
PMN K150332 | NBW Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Lite Blood Glucose Monitoring System	2015-11-01
PMN K150332 | LFR Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Lite Blood Glucose Monitoring System	2015-11-01
PMN K120568 | NBW Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle lnsuLinx Blood Glucose Monitoring System	2012-07-12
PMN K120568 | LFR Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle lnsuLinx Blood Glucose Monitoring System	2012-07-12
PMN K092638 | NBW Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	Freestyle Freedom Blood Glucose Monitoring System	2010-06-28
PMN K092638 | NBW Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Flash Blood Glucose Monitoring System	2010-06-28
PMN K092638 | NBW Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Blood Glucose Monitoring System	2010-06-28
PMN K092638 | NBW Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FREESTYLE TEST STRIPS	2010-06-28
PMN K092638 | LFR Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	Freestyle Freedom Blood Glucose Monitoring System	2010-06-28
PMN K092638 | LFR Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Flash Blood Glucose Monitoring System	2010-06-28
PMN K092638 | LFR Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Blood Glucose Monitoring System	2010-06-28
PMN K092638 | LFR Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FREESTYLE TEST STRIPS	2010-06-28
PMN K092602 | NBW Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	Freestyle Lite Test Strips	2010-06-08
PMN K092602 | NBW Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Lite Blood Glucose Monitoring System	2010-06-08
PMN K092602 | NBW Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Freedom Lite Blood Glucose Monitoring System	2010-06-08
PMN K092602 | LFR Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	Freestyle Lite Test Strips	2010-06-08
PMN K092602 | LFR Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Lite Blood Glucose Monitoring System	2010-06-08
PMN K092602 | LFR Abbott Ireland Diabetes Care [ABBOTT LABORATORIES]	FreeStyle Freedom Lite Blood Glucose Monitoring System	2010-06-08