Clearance Summary
KINETIC FIBRINOGEN ASSAY received FDA 510(k) clearance under submission number K881150, sponsored by Bio/Data 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 1988-03-28.
- Submission: K881150
- Applicant / Sponsor: Bio/Data Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7340
- Decision date: 1988-03-28
Classification & Regulation
This clearance is catalogued under FDA product code GIS and 21 CFR 864.7340, within the Hematology review panel as a Class II device.