Arkray, Inc.

US Last updated 23 May 2026

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Devices: 18
Registries: FDA 510(k)FDA
FDA recalls: 0

Catalogue18

AUTION MAX AX-4060 Urinalysis System Ref K193514

Class II FDA 510(k) Active
AUTION EYE AI-4510 Urine Particle Analysis System Ref K232416

Class II FDA 510(k) Active
The Polymedco Spotchem Ex Glucose, Fructosamine And Ast Tests Ref K041427

Class II FDA 510(k) Active
Spotchem Ii Calcium, Magnesium, And Blood Urea Nitrogen Tests Ref K050077

Class II FDA 510(k) Active
Arkit HBA1C Ref K030553

Class II FDA 510(k) Active
Polymedco Spotchem Ez Chemistry Analyzer Ref K040332

Class I FDA 510(k) Active
Aution Max Model Ax-4030 Urinalysis System Ref K093098

Class I FDA 510(k) Active
Spotchem Ii Ldh Test Ref K050790

Class II FDA 510(k) Active
Aution Hybrid Au-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control Ref K121456

Class I FDA 510(k) Active
Spotchem Hdl, Total Cholesterol And Triglyceride Reagent Tests And Panel Ref K042443

Class I FDA 510(k) Active
Assure Titanium Blood Glucose Monitoring System Ref K200788

Class II FDA 510(k) Active
Multi-Lancet Device 2, ReliOn Premier Lancing Device Ref K221175

Class II FDA 510(k) Active
Pocketchem Ua Aution Sticks 10TA Ref K022386

Class II FDA 510(k) Active
Spotchem Ii Total Bilirubin, Total Protein And Albumin Tests Ref K051432

Class II FDA 510(k) Active
Spotchem Ii Creatinine, Amylase & Alp Tests Ref K050652

Class II FDA 510(k) Active
Spotchem Ii Inoganic Phosphorus, Cpk And Uric Acid Tests Ref K051648

Class II FDA 510(k) Active
Spotchem Ii Chemistry Basic 1 And Chemistry Basic 2 Tests Ref K053401

Class II FDA 510(k) Active
AUTION ELEVEN Semi-Automated Urinalysis System Ref K160062

Class II FDA 510(k) Active

FDA establishments1

Registered with the FDA under this company group, matched by name.

Arkray, Inc. Kamigyo-ku Kyoto · JP FEI 3002807423

What Arkray, Inc. makes

Arkray, Inc. manufactures urinalysis systems, urine particle analysis systems, blood glucose monitoring systems, lancing devices, and various reagent tests for glucose, fructosamine, AST, calcium, magnesium, blood urea nitrogen, LDH, HDL, total cholesterol, and triglycerides.

The company's portfolio includes Class I and Class II devices listed in the FDA 510(k) registry, and it is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does Arkray, Inc. manufacture?

Where is Arkray, Inc. based?

Arkray, Inc. is based in the United States, as indicated by the country information provided in the device data.

Which regulatory registries list Arkray, Inc.'s devices?

Arkray, Inc.'s devices are listed in the FDA 510(k) registry, which is the only registry mentioned in the provided device data.

How are Arkray, Inc.'s devices classified?

Arkray, Inc.'s devices are classified as Class I and Class II medical devices, as specified in the device data. These classifications indicate the level of regulatory control applied to the devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US

Catalogue18

AUTION MAX AX-4060 Urinalysis System Ref K193514

AUTION EYE AI-4510 Urine Particle Analysis System Ref K232416

The Polymedco Spotchem Ex Glucose, Fructosamine And Ast Tests Ref K041427

Spotchem Ii Calcium, Magnesium, And Blood Urea Nitrogen Tests Ref K050077

Arkit HBA1C Ref K030553

Polymedco Spotchem Ez Chemistry Analyzer Ref K040332

Aution Max Model Ax-4030 Urinalysis System Ref K093098

Spotchem Ii Ldh Test Ref K050790

Aution Hybrid Au-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control Ref K121456

Spotchem Hdl, Total Cholesterol And Triglyceride Reagent Tests And Panel Ref K042443

Assure Titanium Blood Glucose Monitoring System Ref K200788

Multi-Lancet Device 2, ReliOn Premier Lancing Device Ref K221175

Pocketchem Ua Aution Sticks 10TA Ref K022386

Spotchem Ii Total Bilirubin, Total Protein And Albumin Tests Ref K051432

Spotchem Ii Creatinine, Amylase & Alp Tests Ref K050652

Spotchem Ii Inoganic Phosphorus, Cpk And Uric Acid Tests Ref K051648

Spotchem Ii Chemistry Basic 1 And Chemistry Basic 2 Tests Ref K053401

AUTION ELEVEN Semi-Automated Urinalysis System Ref K160062

FDA establishments1

What Arkray, Inc. makes

Frequently asked questions

Information