Clearance Summary
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM received FDA 510(k) clearance under submission number K093098, sponsored by Arkray, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2009-12-23.
- Submission: K093098
- Applicant / Sponsor: Arkray, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2900
- Decision date: 2009-12-23
Classification & Regulation
This clearance is catalogued under FDA product code KQO and 21 CFR 862.2900, within the Clinical Chemistry review panel as a Class I device.