Clearance Summary
HEMATOXYLIN received FDA 510(k) clearance under submission number K811802, sponsored by Richard-Allan Medical Ind., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1981-07-28.
- Submission: K811802
- Applicant / Sponsor: Richard-Allan Medical Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1981-07-28
Classification & Regulation
This clearance is catalogued under FDA product code HYJ and 21 CFR 864.1850, within the Hematology review panel as a Class I device.