Data / Medical devices / Japan / ARKRAY Factory, Inc.
ARKRAY Factory, Inc.: FDA-registered device maker in Koka-shi Shiga, Japan, 7 510(k) clearances
ARKRAY Factory, Inc. is registered with the FDA (registration 3003422726) in Koka-shi Shiga, Japan. It lists 20 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003422726
- Address
- 1480 Koji, Konan-cho, Koka-shi Shiga, Japan, 520-3306
- Owner or operator
- ARKRAY FACTORY USA, Inc. (8030316)
- Roles
- Manufacturer
- First device listed
- December 4, 2001
- Registered through
- 2026
- Brand names listed
- ADAMS A1c HA-8180V, AUTION ELEVEN AE-4022 Semi-Automated Urinalysis System, AUTION EYE AI-4510, AUTION MAX AX-4030, AUTION MAX AX-4060 Urinalysis System, AUTION Sticks 10EA Test Strips, AUTION Sticks 9EB, Calibrator 80 and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 3, 2024 | K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | LKM | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| April 13, 2023 | K193514 | AUTION MAX AX-4060 Urinalysis System | JIL | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| October 17, 2022 | K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | QRL | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| June 29, 2017 | K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | PDJ | Substantially Equivalent | Arkray Factory, Inc. | accessdata.fda.gov |
| October 7, 2016 | K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | JIL | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| December 23, 2009 | K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | KQO | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| October 21, 2008 | K082417 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 | CGA | Substantially Equivalent | Arkray Factory USA, Inc. | accessdata.fda.gov |
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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.