Clearance Summary
CORNING CELL WELLS-MULTIPLE WELL PLATES received FDA 510(k) clearance under submission number K853634, 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 1985-09-16.
- Submission: K853634
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2240
- Decision date: 1985-09-16
Classification & Regulation
This clearance is catalogued under FDA product code KIZ and 21 CFR 864.2240, within the Hematology review panel as a Class I device.