Arkray, Inc.
Kamigyo-ku, JP
ARKRAY, INC. appears in FDA device records in Kamigyo-ku, JP. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Arkray, Inc. between 2002 and 2024. The busiest year on record is 2005, with 4. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 4 |
| 2006 | 2 |
| 2009 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | LKM | Substantially Equivalent | |
| K193514 | AUTION MAX AX-4060 Urinalysis System | JIL | Substantially Equivalent | |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | QRL | Substantially Equivalent | |
| K200788 | Assure Titanium Blood Glucose Monitoring System | PZI | Substantially Equivalent | |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | JIL | Substantially Equivalent | |
| K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL | KQO | Substantially Equivalent | |
| K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | KQO | Substantially Equivalent | |
| K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | CIC | Substantially Equivalent | |
| K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | CGS | Substantially Equivalent | |
| K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS | CIG | Substantially Equivalent | |
| K050790 | SPOTCHEM II LDH TEST | CFH | Substantially Equivalent | |
| K050652 | SPOTCHEM II CREATININE, AMYLASE & ALP TESTS | CGX | Substantially Equivalent | |
| K050077 | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS | CIC | Substantially Equivalent | |
| K042443 | SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL | CHH | Substantially Equivalent | |
| K041427 | THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS | CGA | Substantially Equivalent | |
| K040332 | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER | JJF | Substantially Equivalent | |
| K030553 | ARKIT HBA1C | LCP | Substantially Equivalent | |
| K022386 | POCKETCHEM UA AUTION STICKS 10TA | JIL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9611444 | 3002807423 | ARKRAY, INC. | Yousuien-nai, Kamigyo-ku Kyoto 602-0008 JP | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- LCPAssay, Glycosylated Hemoglobin
- KQOAutomated Urinalysis System
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- JITCalibrator, Secondary
- LKMCounter, Urine Particle
- CICCresolphthalein Complexone, Calcium
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CIGDiazo Colorimetry, Bilirubin
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PPMGeneral Purpose Reagent
- CGAGlucose Oxidase, Glucose
- PDJHemoglobin A1c Test System
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- LDMInstrumentation, High Pressure Liquid Chromatography
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- PZIPrescription Use Blood Glucose Meter For Near-Patient Testing
- JRERefractometer For Clinical Use
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- NBWSystem, Test, Blood Glucose, Over The Counter
- LJXTest, Urine Leukocyte
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain