Clearance Summary
KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP received FDA 510(k) clearance under submission number K771925, sponsored by Harleco. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1977-11-02.
- Submission: K771925
- Applicant / Sponsor: Harleco
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3010
- Decision date: 1977-11-02
Classification & Regulation
This clearance is catalogued under FDA product code KES and 21 CFR 864.3010, within the Pathology review panel as a Class I device.