Arkray, Inc. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
AUTION EYE AI-4510 Urine Particle Analysis System510(k)May 3, 2024Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	May 3, 2024
AUTION MAX AX-4060 Urinalysis System510(k)Apr 13, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Apr 13, 2023
Multi-Lancet Device 2, ReliOn Premier Lancing Device510(k)Oct 17, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Oct 17, 2022
Assure Titanium Blood Glucose Monitoring System510(k)May 23, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Dual Track)	May 23, 2022