Clearance Summary
ENTELLAN received FDA 510(k) clearance under submission number K800847, sponsored by Mcb Manufacturing Chemists, 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 1980-05-08.
- Submission: K800847
- Applicant / Sponsor: Mcb Manufacturing Chemists, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1980-05-08
Classification & Regulation
This clearance is catalogued under FDA product code KEP and 21 CFR 864.4010, within the Pathology review panel as a Class I device.