Clearance Summary
ACON UTI URINARY TRACT INFECTION TEST STRIPS received FDA 510(k) clearance under submission number K063295, sponsored by ACON Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2007-10-12.
- Submission: K063295
- Applicant / Sponsor: ACON Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.7675
- Decision date: 2007-10-12
Classification & Regulation
This clearance is catalogued under FDA product code LJX and 21 CFR 864.7675, within the Hematology review panel as a Class I device.