Clearance Summary
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM received FDA 510(k) clearance under submission number K032482, sponsored by Stanbio Laboratory. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2003-10-24.
- Submission: K032482
- Applicant / Sponsor: Stanbio Laboratory
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5620
- Decision date: 2003-10-24
Classification & Regulation
This clearance is catalogued under FDA product code GKR and 21 CFR 864.5620, within the Hematology review panel as a Class II device.