Clearance Summary
LOW-TOX-H RABBIT COMPLEMENT received FDA 510(k) clearance under submission number K790380, sponsored by Cederlane Labs , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1979-03-21.
- Submission: K790380
- Applicant / Sponsor: Cederlane Labs , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4100
- Decision date: 1979-03-21
Classification & Regulation
This clearance is catalogued under FDA product code KTQ and 21 CFR 866.4100, within the Immunology review panel as a Class I device.