Clearance Summary
ACON URINALYSIS REAGENT STRIPS received FDA 510(k) clearance under submission number K061559, sponsored by Acon Laboratories Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2006-08-11.
- Submission: K061559
- Applicant / Sponsor: Acon Laboratories Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1785
- Decision date: 2006-08-11
Classification & Regulation
This clearance is catalogued under FDA product code CDM and 21 CFR 862.1785, within the Clinical Chemistry review panel as a Class I device.