FDA.reportPublic FDA data

Abbott Ireland Diabetes Care

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30070311033007031103Abbott Ireland Diabetes Care1N2026-01-01Donegal Town, Co. Donegal Donegal Town IE Donegal

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
877551247953832K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemLFR2015-09-17
877551752609291K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemNBW2015-06-05
877551314706277K150332FreeStyle Lite Blood Glucose Monitoring SystemNBW2015-06-05
877551891318144K120568FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMNBW2012-03-29
877551089075446K092638FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23NBW2010-06-15
877551530081385K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring SystemNBW2010-05-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW62015-06-05
LFR12015-09-17