Clearance Summary
ANTI-GM & ANTI-KM TYPING SERUMS received FDA 510(k) clearance under submission number K812076, sponsored by Biotest-Serum-Institut. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1981-08-12.
- Submission: K812076
- Applicant / Sponsor: Biotest-Serum-Institut
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 1981-08-12
Classification & Regulation
This clearance is catalogued under FDA product code DGH and 21 CFR 866.5510, within the Immunology review panel as a Class II device.