Clearance Summary
B-FACT, BORDERLINE FACTOR ASSAY CONTROL received FDA 510(k) clearance under submission number K945854, sponsored by George King Bio-Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1995-10-24.
- Submission: K945854
- Applicant / Sponsor: George King Bio-Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 1995-10-24
Classification & Regulation
This clearance is catalogued under FDA product code GGN and 21 CFR 864.5425, within the Hematology review panel as a Class II device.