Clearance Summary
KOH MOUNTING FLUID received FDA 510(k) clearance under submission number K812193, sponsored by American Scientific Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1981-08-31.
- Submission: K812193
- Applicant / Sponsor: American Scientific Products
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1981-08-31
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.