Clearance Summary
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III received FDA 510(k) clearance under submission number K864137, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1986-11-07.
- Submission: K864137
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1986-11-07
Classification & Regulation
This clearance is catalogued under FDA product code KIJ and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.