Clearance Summary
HEMASTAIN PHOSPHATE BUFFER received FDA 510(k) clearance under submission number K760487, sponsored by Geometric Data, Div. Smithkline Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1976-08-30.
- Submission: K760487
- Applicant / Sponsor: Geometric Data, Div. Smithkline Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1976-08-30
Classification & Regulation
This clearance is catalogued under FDA product code KQC and 21 CFR 864.1850, within the Hematology review panel as a Class I device.