Clearance Summary
LEUKOSTIX REAGENT STRIPS FOR URINALYSIS received FDA 510(k) clearance under submission number K843727, sponsored by Miles 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 1985-01-04.
- Submission: K843727
- Applicant / Sponsor: Miles Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.7675
- Decision date: 1985-01-04
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.