Clearance Summary
LACTO-PHENOL COTTON BLUE MOUNTING FL. received FDA 510(k) clearance under submission number K760838, sponsored by I M, 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 1976-11-16.
- Submission: K760838
- Applicant / Sponsor: I M, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1976-11-16
Classification & Regulation
This clearance is catalogued under FDA product code LEB and 21 CFR 864.4010, within the Pathology review panel as a Class I device.