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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list ARKRAY and its 3 subsidiaries with 34 510(k) clearances, 3 device recalls and 1 AI-enabled device. The most recent is a 510(k) clearance dated May 3, 2024: AUTION EYE AI-4510 Urine Particle Analysis System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, ARKRAY and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 3, 2024 | AUTION EYE AI-4510 Urine Particle Analysis SystemK232416 · LKM | 510(k) clearances |
| May 3, 2024 | AUTION EYE AI-4510 Urine Particle Analysis SystemK232416 · Hematology | AI-enabled devices |
| Apr 13, 2023 | AUTION MAX AX-4060 Urinalysis SystemK193514 · JIL | 510(k) clearances |
| Oct 17, 2022 | Multi-Lancet Device 2, ReliOn Premier Lancing DeviceK221175 · QRL | 510(k) clearances |
| May 23, 2022 | Assure Titanium Blood Glucose Monitoring SystemK200788 · PZI | 510(k) clearances |
| May 3, 2019 | AUTION HYBRID AU-4050Class II · This correction is being initiated due to a software issue which results in the possibility of incorrect patient informa | Device recalls |
| 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 |
| Oct 7, 2016 | AUTION ELEVEN Semi-Automated Urinalysis SystemK160062 · JIL | 510(k) clearances |
| Dec 18, 2015 | arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose,Class I · One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recall | Device recalls |
| Dec 18, 2015 | arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determinationClass I · One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recall | Device recalls |
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
