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BIONIME USA CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30067555413006755541BIONIME USA CORPORATION1Y2026-01-011450 E. Spruce Street, Bldg. #B Ontario CA US 91761

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
850841969584604K240637RIGHTEST Blood Glucose Monitoring System Max TelNBW2024-11-04
850841021754976K221507Disposable Blood LancetQRK2022-08-31
850841629823821K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceQRL2022-09-26
850841599850410K220475Lancet (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
850841311459048K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SBNBW2019-06-02
850841705995075K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max PlusNBW2018-08-17
850841038573704K173139Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz PlusNBW2018-06-19
850842024705012K170143GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,NBW2017-07-06
850841849256039K143387GE333 Blood Glucose Monitoring SystemNBW2015-06-03
850841529389614K141292Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring SystemNBW2015-06-09
850841373873129K140210RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720NBW2014-08-22
850841771973722K133522RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEMNBW2014-04-17
850842049421445K133003RIGHTEST CONTROL SOLUTIONJJX2013-10-24
850841147688623K123008RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORINNBW2013-01-25
850841112784821K113007BIONIME DIABETES MANAGEMENT SYSTEM VI.0JQP2012-02-27
850841904948663K110737RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700NBW2012-03-29
850842035156941K092052RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550NBW2010-06-18
850841712900428K081451RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100NBW2008-09-18
850841702825520K062567RIGHTEST BLOOD GLUCOSE MONITORING SYSTEMNBW2007-02-16
850841865418947K053635MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEMNBW2006-02-21
850841483802764K042678RIGHTEST BLOOD GLUCOSE MONITORING SYSTEMNBW2005-01-03
850841108195467

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW162024-11-04
QRL22022-09-26
QRK12022-08-31
JJX12013-10-24
JQP12012-02-27