ARKRAY Factory, Inc.
Koka-shi Shiga, JP
ARKRAY Factory, Inc. appears in FDA device records in Koka-shi Shiga, JP. FDA records list 6 510(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 6 510(k) clearances for ARKRAY Factory, Inc. between 2014 and 2019. The busiest year on record is 2014, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 3 |
| 2017 | 2 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K183306 | GLUCOCARD® W onyx Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K170064 | GLUCOCARD W Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | PDJ | Substantially Equivalent | |
| K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System | CGA | Substantially Equivalent | |
| K142035 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K124021 | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003422726 | 3003422726 | ARKRAY Factory, Inc. | 1480 Koji, Konan-cho, Koka-shi Shiga 520-3306 JP | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- 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
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- CGAGlucose Oxidase, Glucose
- PDJHemoglobin A1c Test System
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- JRERefractometer For Clinical Use
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- NBWSystem, Test, Blood Glucose, Over The Counter
- LJXTest, Urine Leukocyte
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