Clearance Summary
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) received FDA 510(k) clearance under submission number K981174, sponsored by Precision Biologicals, 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 1999-01-13.
- Submission: K981174
- Applicant / Sponsor: Precision Biologicals, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7290
- Decision date: 1999-01-13
Classification & Regulation
This clearance is catalogued under FDA product code GJT and 21 CFR 864.7290, within the Hematology review panel as a Class II device.