Clearance Summary
HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED received FDA 510(k) clearance under submission number K881477, sponsored by Stat Path. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1988-04-18.
- Submission: K881477
- Applicant / Sponsor: Stat Path
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1988-04-18
Classification & Regulation
This clearance is catalogued under FDA product code KEL and 21 CFR 864.4010, within the Pathology review panel as a Class I device.