Clearance Summary
TUBE, STAIN, RETICULOCYTE, LARC received FDA 510(k) clearance under submission number K770792, 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 1977-07-05.
- Submission: K770792
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1977-07-05
Classification & Regulation
This clearance is catalogued under FDA product code KFC and 21 CFR 864.1850, within the Hematology review panel as a Class I device.