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Data / Medical devices / Japan / Arkray, Inc.

Arkray, Inc.: FDA-registered device maker in Kamigyo-ku Kyoto, Japan, 12 510(k) clearances

Arkray, Inc. is registered with the FDA (registration 9611444) in Kamigyo-ku Kyoto, Japan. It lists 24 device types. The FDA files 12 510(k) clearances under its listings, the newest dated May 3, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Arkray, Inc.
FDA registration number
9611444
FEI number
3002807423
Address
Yousuien-nai 59 Gansuin-cho, Kamigyo-ku Kyoto, Japan, 602-0008
Owner or operator
ARKRAY FACTORY USA, Inc. (8030316)
Roles
Specification developer
First device listed
December 4, 2001
Registered through
2026
Brand names listed
ADAMS A1c HA-8180V, AUTION CHECK Plus, AUTION ELEVEN AE-4022 Semi-Automated Urinalysis System, AUTION EYE AI-4510, AUTION EYE Calibrator, AUTION EYE Control Solution, AUTION EYE Sheath Solution, AUTION MAX AX-4030 and more

Devices it lists

DeviceProduct codeClassRoleSource
Assay, Glycosylated HemoglobinLCP2Specification developeraccessdata.fda.gov
Automated Urinalysis SystemKQO1Specification developeraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Specification developeraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Specification developeraccessdata.fda.gov
Calibrator, SecondaryJIT2Specification developeraccessdata.fda.gov
Counter, Urine ParticleLKM2Specification developeraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Specification developeraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Specification developeraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Specification developeraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Specification developeraccessdata.fda.gov
General Purpose ReagentPPM1Specification developeraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Specification developeraccessdata.fda.gov
Hemoglobin A1c Test SystemPDJ2Specification developeraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Specification developeraccessdata.fda.gov
Instrumentation, High Pressure Liquid ChromatographyLDM1Specification developeraccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Specification developeraccessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use OnlyQRL2Specification developeraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Specification developeraccessdata.fda.gov
Prescription Use Blood Glucose Meter For Near-Patient TestingPZI2Specification developeraccessdata.fda.gov
Refractometer For Clinical UseJRE1Specification developeraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Specification developeraccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Specification developeraccessdata.fda.gov
Test, Urine LeukocyteLJX1Specification developeraccessdata.fda.gov
Urinalysis Controls (Assayed And Unassayed)JJW1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 3, 2024K232416AUTION EYE AI-4510 Urine Particle Analysis SystemLKMSubstantially EquivalentArkray, Inc.accessdata.fda.gov
April 13, 2023K193514AUTION MAX AX-4060 Urinalysis SystemJILSubstantially EquivalentArkray, Inc.accessdata.fda.gov
October 17, 2022K221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceQRLSubstantially EquivalentArkray, Inc.accessdata.fda.gov
May 23, 2022K200788Assure Titanium Blood Glucose Monitoring SystemPZISubstantially EquivalentArkray, Inc.accessdata.fda.gov
June 29, 2017K162822ADAMS A1c HA-8180V, CALIBRATOR 80PDJSubstantially EquivalentArkray Factory, Inc.accessdata.fda.gov
October 7, 2016K160062AUTION ELEVEN Semi-Automated Urinalysis SystemJILSubstantially EquivalentArkray, Inc.accessdata.fda.gov
April 10, 2015K142262AUTION CHECK PLUSJJWSubstantially EquivalentQuantimetrix Corp.accessdata.fda.gov
June 30, 2014K124021ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEMCGASubstantially EquivalentArkray Factory, Inc.accessdata.fda.gov
December 23, 2009K093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMKQOSubstantially EquivalentArkray, Inc.accessdata.fda.gov
November 24, 2009K092104ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEMCGASubstantially EquivalentArkray Factory USA, Inc.accessdata.fda.gov
October 23, 2009K091102ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMSCGASubstantially EquivalentArkray Factory USA, Inc.accessdata.fda.gov
October 21, 2008K082417GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110CGASubstantially EquivalentArkray Factory USA, Inc.accessdata.fda.gov

Compare with other makers

Updated May 3, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.