FDA.reportPublic FDA data

Yoon Ha Cha

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30056212223005621222Yoon Ha Cha1N2026-01-013545 Lomita Blvd., Unit D Torrance CA US 90505
30073821603007382160Yoon Ha Cha1N2026-01-013545 Lomita Blvd., Unit D Torrance CA US 90505
30112136053011213605Yoon Ha Cha1N2026-01-013545 Lomita Blvd., Unit D Torrance CA US 90505

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1729681941827549K230625ReliOn Premier BLU Blood Glucose Monitoring SystemNBW2023-08-10
944761941827549K230625ReliOn Premier BLU Blood Glucose Monitoring SystemNBW2023-08-10
663661941827549K230625ReliOn Premier BLU Blood Glucose Monitoring SystemNBW2023-08-10
944761250611672K222656LDE4 Lancing DeviceQRL2022-11-23
663661250611672K222656LDE4 Lancing DeviceQRL2022-11-23
944761327689454K222034RightLance Blood Lancing SystemQRL2022-09-07
1729681347231344K220475Lancet (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
944761347231344K220475Lancet (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
944761077204661K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)FMK2022-05-19
944762055667759K201551KetoSens BT Blood B-Ketone Monitoring SystemJIN2020-09-09
663662055667759K201551KetoSens BT Blood B-Ketone Monitoring SystemJIN2020-09-09
944761935849326K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SystemNBW2021-10-05
1729681935849326K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SystemNBW2021-10-05
663661935849326K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SystemNBW2021-10-05
944761666374281K193590CareSens S Fit BT Blood Glucose Monitoring SystemNBW2020-01-17
663661666374281K193590CareSens S Fit BT Blood Glucose Monitoring SystemNBW2020-01-17
944761958585977K192859CareSens S Clear BT Blood Glucose Monitoring SystemNBW2020-01-24
663661958585977K192859CareSens S Clear BT Blood Glucose Monitoring SystemNBW2020-01-24
1729681223114381K192220ReliOn Premier Classic Blood Glucose Monitoring SystemNBW2019-12-13
944761223114381K192220ReliOn Premier Classic Blood Glucose Monitoring SystemNBW2019-12-13
663661223114381K192220ReliOn Premier Classic Blood Glucose Monitoring SystemNBW2019-12-13
944761312901126K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring SystemNBW2018-11-01
1729681312901126K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring SystemNBW2018-11-01
663661312901126K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring SystemNBW2018-11-01
663661046143557K180866CareSens S Fit Blood Glucose Monitoring SystemNBW2018-08-31
944761046143557K180866CareSens S Fit Blood Glucose Monitoring SystemNBW2018-08-31
944761405973364K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemNBW2017-12-13
663661405973364K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemNBW2017-12-13
1729681405973364K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemNBW2017-12-13
1729681558451959K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SystemNBW2017-10-19
944761558451959K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SystemNBW2017-10-19
663661558451959K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SystemNBW2017-10-19
663661137510298K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN2018-04-13
944761137510298K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN2018-04-13
663661263965417K160742NoCoding1 Plus Blood Glucose Monitoring SystemNBW2016-12-16
944761263965417K160742NoCoding1 Plus Blood Glucose Monitoring SystemNBW2016-12-16
663661533561813K151164Assure Prism multi Blood Glucose Monitoring SystemNBW2015-08-07
944761533561813K151164Assure Prism multi Blood Glucose Monitoring SystemNBW2015-08-07
663661033919421K133346SMARTLOG DIABETES MANAGEMENT SOFTWARENBW2013-12-19
944761530635007K132288CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METERNBW2013-11-22
663661530635007K132288CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METERNBW2013-11-22
1729681530635007K132288CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METERNBW2013-11-22
944761631892036K131419ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEMNBW2013-08-09
663661631892036K131419ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEMNBW2013-08-09
944761238672348K121654AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTIONCGA2012-09-05
663661238672348K121654AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTIONCGA2012-09-05
944761108507182K121133CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEMNBW2012-07-10
1729681108507182K121133CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEMNBW2012-07-10
663661108507182K121133CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEMNBW2012-07-10
944761731552469K120759CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTIONCGA2012-06-05
663661731552469K120759CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTIONCGA2012-06-05
1729681731552469K120759CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTIONCGA2012-06-05
944761013263631K120351CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CANBW2012-05-03
663661013263631K120351CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CANBW2012-05-03
1729681013263631K120351CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CANBW2012-05-03
944761866570622K103396COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTIONNBW2011-09-27
663661866570622K103396COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTIONNBW2011-09-27
663661591254637K103278ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTIONCGA2011-10-28
944761591254637K103278ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTIONCGA2011-10-28
663662049778479K100937PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARENBW2010-12-21
944762049778479K100937PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARENBW2010-12-21
1729681911460577K092104ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEMCGA2009-11-24
1729681129639528K091102ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMSCGA2009-10-23
663661388743255K083468CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)NBW2009-02-10
944761388743255K083468CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)NBW2009-02-10
1729681388743255K083468CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)NBW2009-02-10
663661941819905K080923CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EBNBW2008-10-17
944761941819905K080923CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EBNBW2008-10-17
663661957252698K052762LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067NBW2006-01-23
944761957252698K052762LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067NBW2006-01-23
663661973826885
944761973826885
1729681306152611
944761493447121
1729681557775044
1729681760288732

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW512023-08-10
CGA92012-09-05
QRL52022-11-23
JIN42020-09-09
FMK12022-05-19