Clearance Summary
FROSTED GLASS SLIDES received FDA 510(k) clearance under submission number K820100, sponsored by Stan-Pak Ent.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1982-03-04.
- Submission: K820100
- Applicant / Sponsor: Stan-Pak Ent.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3010
- Decision date: 1982-03-04
Classification & Regulation
This clearance is catalogued under FDA product code KEW and 21 CFR 864.3010, within the Pathology review panel as a Class I device.