Clearance Summary
XYLENE received FDA 510(k) clearance under submission number K812847, sponsored by Richard-Allan Medical Ind., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1981-10-29.
- Submission: K812847
- Applicant / Sponsor: Richard-Allan Medical Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1981-10-29
Classification & Regulation
This clearance is catalogued under FDA product code KEM and 21 CFR 864.4010, within the Pathology review panel as a Class I device.