Clearance Summary
HEMA-TEK II SLIDE STAINER received FDA 510(k) clearance under submission number K771559, sponsored by Miles Laboratories, 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 1977-08-25.
- Submission: K771559
- Applicant / Sponsor: Miles Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3800
- Decision date: 1977-08-25
Classification & Regulation
This clearance is catalogued under FDA product code KPA and 21 CFR 864.3800, within the Pathology review panel as a Class I device.