ARKRAY, INC.

FDA Device Registration & Listing · Kamigyo-ku Kyoto, JP · Registration 9611444

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9611444
FEI Number
3002807423
Entity Name
ARKRAY, INC.
City/State/Country
Kamigyo-ku Kyoto, JP
Establishment Address
Yousuien-nai, 59 Gansuin-cho,, Kamigyo-ku Kyoto 602-0008, JP
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
N
Expiration Date (Year)
2026
510(k) Number
K221175
PMA Number
N/A

All Registered Proprietary Names

Assure Platinum BGM System AUTION Sticks 10EA Test Strips AUTION ELEVEN AE-4022 Semi-Automated Urinalysis System AUTION EYE Control Solution AUTION EYE Sheath Solution AUTION EYE Calibrator Concentrated Washing Solution 3 AUTION EYE Sheath Solution ReliOn Prime BGM System GLUCOCARD Vital BGM System GLUCOCARD Vital Blood Glucose Test Strips AUTION MAX AX-4030 AUTION Sticks 9EB AUTION CHECK Plus ADAMS A1c HA-8180V Calibrator 80 COLUMN UNIT 80; ELUENT 80A; ELUENT 80B; ELUENT 80CV; Hemolysis Washing Solution 80H; Control Dilution Set 80 Assure Control Control Solution 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 SillHa paper Test Strip Kit SillHa LH-4912 Oral Wellness System AUTION MAX AX-4060 Urinalysis System AUTION Sticks 9EB AUTOMATED URINALYSIS SYSTEM AUTION Sticks 9EB AX-4280 ReliOn Premier Lancing Device Multi-Lancet Device 2

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 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
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
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2024-12-02
PPM General Purpose Reagent Pathology Class 1 864.4010 2015-05-28
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
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2010-04-29
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2010-04-29
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2010-04-29
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2010-04-29
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2010-04-29
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2010-04-29
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2010-04-29
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2010-04-29
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2010-04-29
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2010-04-29
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2010-04-29
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-05-03
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
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 2025-09-04
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
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2018-04-27
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
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
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2022-11-04

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
3003422726 ARKRAY Factory, Inc. Koka-shi Shiga, JP
1832816 ARKRAY FACTORY USA, INC. Miami, FL, US

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
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23

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-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611444. Last updated year: 2026. Please use registration number 9611444 when referencing this establishment in official correspondence.
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