Clearance Summary
SCRIPPSERA COMPLEMENT CONTROL SERA received FDA 510(k) clearance under submission number K811433, sponsored by Scripps-Miles, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1981-06-16.
- Submission: K811433
- Applicant / Sponsor: Scripps-Miles, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4100
- Decision date: 1981-06-16
Classification & Regulation
This clearance is catalogued under FDA product code DHL and 21 CFR 866.4100, within the Immunology review panel as a Class I device.