Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of ARKRAYLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Arkray Factory with 6 510(k) clearances. The most recent is a 510(k) clearance dated Apr 10, 2019: GLUCOCARD® W onyx Blood Glucose Monitoring System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 10, 2019 | GLUCOCARD® W onyx Blood Glucose Monitoring SystemK183306 · NBW | 510(k) clearances |
| Aug 16, 2017 | GLUCOCARD W Blood Glucose Monitoring SystemK170064 · NBW | 510(k) clearances |
| Jun 29, 2017 | ADAMS A1c HA-8180V, CALIBRATOR 80K162822 · PDJ | 510(k) clearances |
| Sep 17, 2014 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring SystemK142336 · CGA | 510(k) clearances |
| Sep 5, 2014 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEMK142035 · NBW | 510(k) clearances |
| Jun 30, 2014 | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEMK124021 · CGA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
