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Arkray, Inc.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories4
Latest FDA decision2024-05-03
TypeNumberDevice NameCodeDateActions
510(k) K232416 AUTION EYE AI-4510 Urine Particle Analysis SystemLKM2024-05-03 View
510(k) K193514 AUTION MAX AX-4060 Urinalysis SystemJIL2023-04-13 View
510(k) K221175 Multi-Lancet Device 2, ReliOn Premier Lancing DeviceQRL2022-10-17 View
510(k) K200788 Assure Titanium Blood Glucose Monitoring SystemPZI2022-05-23 View
510(k) K160062 AUTION ELEVEN Semi-Automated Urinalysis SystemJIL2016-10-07 View
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