Clearance Summary
FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN received FDA 510(k) clearance under submission number K023362, sponsored by Fisher Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2002-12-09.
- Submission: K023362
- Applicant / Sponsor: Fisher Diagnostics
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5400
- Decision date: 2002-12-09
Classification & Regulation
This clearance is catalogued under FDA product code GKP and 21 CFR 864.5400, within the Hematology review panel as a Class II device.