Clearance Summary
FETAL BOVINE SERUM received FDA 510(k) clearance under submission number K802418, sponsored by S&S Biologicals. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1980-10-31.
- Submission: K802418
- Applicant / Sponsor: S&S Biologicals
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2800
- Decision date: 1980-10-31
Classification & Regulation
This clearance is catalogued under FDA product code KIS and 21 CFR 864.2800, within the Hematology review panel as a Class I device.