Clearance Summary
CORNING BLOOD COLLECTION CAPILLARY TUBES received FDA 510(k) clearance under submission number K850806, 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 1985-03-25.
- Submission: K850806
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.6150
- Decision date: 1985-03-25
Classification & Regulation
This clearance is catalogued under FDA product code GIO and 21 CFR 864.6150, within the Hematology review panel as a Class I device.