Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004183148

FEI Number

3004183148

Entity Name

BIONIME CORPORATION

City/State/Country

Taichung City, TW

Establishment Address

NO. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIONIME CORPORATION (Owner Number: 9059262)

Owner / Operator Contact Address

NO. 100, Sec. 2, Daqing St., SOUTH DIST., TAICHUNG CITY, TW-NOTA 40242, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190564

PMA Number

N/A

All Registered Proprietary Names

McKesson Quintet AC Blood Glucose Test Strip McKesson Quintet AC Control Solution McKesson Quintet AC Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System, Model GM550 GE GE100 Blood Glucose Monitoring System Rightest Control Solution GC550 Rightest GM250 Blood Glucose Monitoring System Rightest Blood test Glucose monitoring System GM100 RIGHTEST Blood Test Strip GS100 iGlucose Blood Glucose Monitoring System iGlucose Plus Blood Glucose Monitoring System iGlucose Blood Glucose Test Strip Rightest Blood Glucose Monitoring System GT333 Rightest Blood Glucose Monitoring System GM232 RIGHTEST GT333 Blood Glucose Test Strip RIGHTEST Lancing Device GD500 GE Lancing Device iGlucose Lancing Device Rightest Blood Glucose Test Strip GS300 Rightest Blood Glucose Monitoring System GM300 Rightest Control Solution GC110 Rightest Control Solution GC100 Rightest Control Solution GC310 Rightest Control Solution GC300 RIGHTEST GT333 Control Solution GE200 glucose monitoring system RIGHTEST Blood glucose monitoring System Max Tel iGlucose Touch Control Solution GC700 iGlucose Touch Blood Glucose Test Strips iGlucose Touch Blood Glucose Monitoring System iGlucose Touch Blood Glucose Meter RIGHTEST Blood glucose meter Max Tel RIGHTEST Blood glucose test strip Max RIGHTEST Control Solution GC700 GE Blood Glucose Monitoring System 180 Rightest Blood Glucose Monitoring System GM280 GE Blood Glucose Monitoring System 182 Rightest Blood Glucose Monitoring System GM280B Diathrive+ Bluetooth Blood Glucose Monitoring System Diathrive+ Blood Glucose Monitoring System GE GlucoCapture Cielo Plus Blood Glucose Monitoring System GE GlucoCapture Cielo Blood Glucose Monitoring System Diathrive Blood Glucose Test Strip RIGHTEST Blood Glucose Monitoring System GM700S RIGHTEST Blood Glucose Monitoring System GM700SB RIGHTEST Control Solution GC700

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2010-06-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2010-06-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2010-06-21
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2008-09-24
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2008-09-24
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-07-09
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-07-09
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-06-05
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-06-05
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-12-11
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2007-10-29
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-10-29
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-10-28
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-06-10
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-06-10
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2025-03-26
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-07-09
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

Feng-Yu Lee Email: fengyulee@ivddreg.com Phone: (949) 2180929

Related Public Records

Same Entity

BIONIME 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
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10
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
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000
Z-2165-2011	Instrumentation Laboratory Co.	2	Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004183148. Last updated year: 2026. Please use registration number 3004183148 when referencing this establishment in official correspondence.