Clearance Summary
CORNING DISPOSABLE ROLLER BOTTLES received FDA 510(k) clearance under submission number K872076, 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 1987-06-15.
- Submission: K872076
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2240
- Decision date: 1987-06-15
Classification & Regulation
This clearance is catalogued under FDA product code KJB and 21 CFR 864.2240, within the Hematology review panel as a Class I device.