Clearance Summary
FACTOR XI DEFICIENT PLASMA B11D received FDA 510(k) clearance under submission number K843438, sponsored by Sigma Chemical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1984-11-19.
- Submission: K843438
- Applicant / Sponsor: Sigma Chemical Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7290
- Decision date: 1984-11-19
Classification & Regulation
This clearance is catalogued under FDA product code GGP and 21 CFR 864.7290, within the Hematology review panel as a Class II device.