FDA.reportPublic FDA data

I-SENS Songdo Factory 2

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30301866883030186688I-SENS Songdo Factory 21N2026-01-0143-10, Incheon tower-daero 25beon-gil, Yeonsu-gu lncheon Incheon KR 22013

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3218711941827549K230625ReliOn Premier BLU Blood Glucose Monitoring SystemNBW2023-08-10
3218711327689454K222034RightLance Blood Lancing SystemQRL2022-09-07
3218711347231344K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)QRL2022-07-06
3218711077204661K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)FMK2022-05-19
3218712055667759K201551KetoSens BT Blood B-Ketone Monitoring SystemJIN2020-09-09
3218711935849326K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SystemNBW2021-10-05
3218711666374281K193590CareSens S Fit BT Blood Glucose Monitoring SystemNBW2020-01-17
3218711958585977K192859CareSens S Clear BT Blood Glucose Monitoring SystemNBW2020-01-24
3218711312901126K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring SystemNBW2018-11-01
3218711046143557K180866CareSens S Fit Blood Glucose Monitoring SystemNBW2018-08-31
3218711405973364K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemNBW2017-12-13
3218711558451959K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SystemNBW2017-10-19
3218711137510298K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN2018-04-13
3218711533561813K151164Assure Prism multi Blood Glucose Monitoring SystemNBW2015-08-07
3218711530635007K132288CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METERNBW2013-11-22
3218711108507182K121133CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEMNBW2012-07-10
3218711731552469K120759CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTIONCGA2012-06-05
3218711013263631K120351CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CANBW2012-05-03
3218711388743255K083468CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)NBW2009-02-10
3218711549059154
3218711746346829

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW132023-08-10
QRL22022-09-07
JIN22020-09-09
FMK12022-05-19
CGA12012-06-05