Clearance Summary
PROTEIN C DEFICIENT PLASMA received FDA 510(k) clearance under submission number K945857, 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 1995-10-20.
- Submission: K945857
- Applicant / Sponsor: George King Bio-Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7290
- Decision date: 1995-10-20
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.