Clearance Summary
LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH received FDA 510(k) clearance under submission number K063838, sponsored by Thermo Electron OY. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2007-09-27.
- Submission: K063838
- Applicant / Sponsor: Thermo Electron OY
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5600
- Decision date: 2007-09-27
Classification & Regulation
This clearance is catalogued under FDA product code DFC and 21 CFR 866.5600, within the Immunology review panel as a Class II device.