Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1832816

FEI Number

1832816

Entity Name

ARKRAY FACTORY USA, INC.

City/State/Country

Miami, FL, US

Establishment Address

8260 NW 27th Street, Suite 403, Miami, FL 33122, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

ARKRAY FACTORY USA, Inc. (Owner Number: 8030316)

Owner / Operator Contact Address

8260 NW 27th Street, Suite 403, Miami, FL 33122, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191853

PMA Number

N/A

All Registered Proprietary Names

Assure Prism Multi Blood Glucose Monitoring System AUTION EYE AI-4510 ReliOn Premier BLU Blood Glucose Monitoring System AUTION CHECK Plus ReliOn Premier Compact Blood Glucose Monitoring System TechLITE Pen Needles GLUCOCARD 01 SENSOR PLUS Test Strips GLUCOCARD 01 Blood Glucose Monitoring System ReliOn Confirm Blood Glucose Monitoring System ReliOn Confirm/Micro Plus Blood Glucose Test Strips ReliOn Premier Voice Blood Glucose Monitoring System ReliOn Premier Classic Blood Glucose Monitoring System GLUCOCARD 01-mini ReliOn micro Assure Control Control Solution GLUCOCARD Shine Blood Glucose Monitoring System ADAMS A1c HA-8180V Calibrator 80 Abacus 3CP 3-part WBC Differential Analyzer Assure ID Safety Pen Needle Assure Platinum BGM System COLUMN UNIT 80; ELUENT 80A; ELUENT 80B; ELUENT 80CV; Hemolysis Washing Solution 80H; Control Dilution Set 80 ReliOn Prime BGM System GLUCOCARD Vital BGM System GLUCOCARD Vital Blood Glucose Test Strips Assure Lance Plus Safety Lancets Assure Lance Safety Lancets TechLITE Lancet Assure ID Safety Pen Needles TechLITE Pen Needles TechLITE PLUS Pen Needles TechLITE Insulin Syringe AUTION EYE Control Solution AUTION EYE Sheath Solution AUTION EYE Calibrator GLUCOCARD Shine XL Blood Glucose Monitoring System AUTION MAX AX-4060 Urinalysis System AUTION Sticks 9EB ReliOn Premier Lancing Device Multi-Lancet Device 2 Abacus A5AS-1 5-part Laser WBC Differential Analyzer Abacus 5-1 5-part Laser WBC Differential Analyzer ReliOn Premier BLU Blood Glucose Monitoring System AUTOMATED URINALYSIS SYSTEM AUTION Sticks 9EB AX-4280 Assure ID DUO-Shield Safety Pen Needles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-11-03
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2024-09-30
LKM	Counter, Urine Particle	Hematology	Class 2	864.5200	2024-09-30
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2025-03-17
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-05-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2018-08-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2018-08-30
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-08-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-04-12
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2018-11-26
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-12-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-12-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-10-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-10-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-10-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2008-11-06
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-11-06
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2008-11-06
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2025-09-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-06-29
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-12-26
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-12-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-07-24
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2017-07-24
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2017-07-24
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2024-05-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-08-17
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-12-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-12-18
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2009-12-18
LDM	Instrumentation, High Pressure Liquid Chromatography	Clinical Chemistry	Class 1	862.2260	2026-03-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-11-24
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-11-24
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2009-11-24
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-02-14
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2023-09-12
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-09-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-12-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-06-27
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-12-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-07-11
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-07-11
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-07-11
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2024-09-10
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2024-09-10
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2024-09-10
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2024-09-10
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2024-09-10
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2024-09-10
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2024-09-10
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2024-09-10
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2024-09-10
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2024-09-10
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2024-09-10
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-11-04
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2024-05-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-06-29
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-12-11
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2011-07-26
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2011-07-26
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2011-07-26
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2011-07-26
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2011-07-26
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2011-07-26
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2011-07-26
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2011-07-26
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2011-07-26
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2011-07-26
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2011-07-26
NSC	Injector, Pen	General Hospital	Class 2	880.5860	2020-01-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-01-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARKRAY FACTORY USA, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003422726	ARKRAY Factory, Inc.	Koka-shi Shiga, JP
9611444	ARKRAY, INC.	Kamigyo-ku Kyoto, JP

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
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10

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 1832816. Last updated year: 2026. Please use registration number 1832816 when referencing this establishment in official correspondence.