Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006755541

FEI Number

3006755541

Entity Name

BIONIME USA CORPORATION

City/State/Country

Ontario, CA, US

Establishment Address

1450 E. Spruce Street, Bldg. #B, Ontario, CA 91761, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

BIONIME USA CORPORATION (Owner Number: 10024947)

Owner / Operator Contact Address

1450 E. Spruce Street, Bldg. #B, Ontario, CA 91761, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143387

PMA Number

N/A

All Registered Proprietary Names

GE Lancet Rightest Lancet Bionime Rightest Blood Glucose Monitoring System RIGHTEST Blood Glucose Monitoring System GM700SB RIGHTEST Blood Glucose Monitoring System GM700S GE Diabetes Management System Bionime Rightest Diabetes Management System Bionime Rightest Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System, Model GM100 GE GE100 Blood Glucose Monitoring System Rightest Control Solution GC550 Rightest Control Solution Wiz GE 333 Control Solution McKesson Quintet AC Blood Glucose Test Strip Rightest GM250 Blood Glucose Monitoring System PSS World Medical Quintet AC Blood Glucose Monitoring System GE GM550 Blood Glucose Monitoring System McKesson Quintet AC Control Solution Rightest Blood Glucose Monitoring System, Model GM550 Rightest GM260 Blood Glucose Monitoring System McKesson Quintet AC Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System GT100 Rightest GM250S Blood Glucose Monitoring System GE 300 Talking Blood Glucose Monitoring System GE200 Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System GM650 Rightest Blood Glucose Monitoring System GM700 Rightest Blood Glucose Monitoring System GM280 Diathrive+ Bluetooth Blood Glucose Monitoring System GE Blood Glucose Monitoring System 182 Rightest Blood Glucose Monitoring System GM280B GE Blood Glucose Monitoring System 180 Diathrive+ Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System GM700 GE200 Blood Glucose Monitoring System GE300 Talking Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System GM700 Rightest Blood Glucose Monitoring System GM650 Rightest Lancet GE Lancet RIGHTEST Lancing Device GD500 iGlucose Lancing Device GE Lancing Device GE Blood Glucose Monitoring System 333 Rightest Blood Glucose Monitoring System GT333 Rightest Blood Glucose Monitoring System GM232

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-12-13
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-12-13
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-11-16
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-11-16
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2020-01-27
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-12-04
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-12-04
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-12-04
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2014-12-04
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-11-16
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-11-16
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-11-16
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-11-16
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-11-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-11-16
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-11-16
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-04-13
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-04-13
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2020-11-09
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-10-22
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-10-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-10-22
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-09-16
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-09-16
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-12-13
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-12-13
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-04-13
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-04-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIONIME USA CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10
K973662	Boehringer Mannheim Corp.	ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS	1997-12-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006755541. Last updated year: 2026. Please use registration number 3006755541 when referencing this establishment in official correspondence.