Clearance Summary
PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS received FDA 510(k) clearance under submission number K850333, sponsored by Shaban Mfg. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1985-02-27.
- Submission: K850333
- Applicant / Sponsor: Shaban Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3800
- Decision date: 1985-02-27
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.