Clearance Summary
CEPHALINEX ACTIVATED PTT REAGENT received FDA 510(k) clearance under submission number K852195, 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 1985-08-12.
- Submission: K852195
- Applicant / Sponsor: Bio/Data Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7925
- Decision date: 1985-08-12
Classification & Regulation
This clearance is catalogued under FDA product code GGW and 21 CFR 864.7925, within the Hematology review panel as a Class II device.