Clearance Summary
CORNING NORMAL GLYCOSYLATED HEMOGLOBIN received FDA 510(k) clearance under submission number K802884, sponsored by Corning Medical & Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1980-12-22.
- Submission: K802884
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7440
- Decision date: 1980-12-22
Classification & Regulation
This clearance is catalogued under FDA product code JBD and 21 CFR 864.7440, within the Hematology review panel as a Class II device.