Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003422726

FEI Number

3003422726

Entity Name

ARKRAY Factory, Inc.

City/State/Country

Koka-shi Shiga, JP

Establishment Address

1480 Koji, Konan-cho, Koka-shi Shiga 520-3306, JP

Establishment Type(s)

Manufacture Medical Device

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

K082417

PMA Number

N/A

All Registered Proprietary Names

SillHa paper Test Strip Kit SillHa LH-4912 Oral Wellness System ADAMS A1c HA-8180V Calibrator 80 AUTION MAX AX-4060 Urinalysis System AUTION Sticks 9EB S.G. Calibrator H ReliOn Premier Lancing Device Multi-Lancet Device 2 AUTOMATED URINALYSIS SYSTEM AUTION Sticks 9EB AX-4280 AUTION EYE AI-4510 AUTION Sticks 10EA Test Strips AUTION ELEVEN AE-4022 Semi-Automated Urinalysis System GLUCOCARD 01-mini ReliOn micro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2018-04-27
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
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
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2001-12-04
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-11-04
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
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
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2016-11-18
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2016-11-18
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2016-11-18
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2016-11-18
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2016-11-18
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2016-11-18
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2016-11-18
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2016-11-18
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2016-11-18
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2016-11-18
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2016-11-18
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

Official Correspondent

No official correspondent registered.

US Agent Details

Yosuke Yamamoto Email: yamamotoy@arkrayusa.com Phone: (612) 9461481

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
9611444	ARKRAY, INC.	Kamigyo-ku Kyoto, JP
1832816	ARKRAY FACTORY USA, INC.	Miami, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16
K103548	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491	2011-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003422726. Last updated year: 2026. Please use registration number 3003422726 when referencing this establishment in official correspondence.