Clearance Summary
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT received FDA 510(k) clearance under submission number K103757, sponsored by Grifols. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2011-10-13.
- Submission: K103757
- Applicant / Sponsor: Grifols
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 2011-10-13
Classification & Regulation
This clearance is catalogued under FDA product code CFF and 21 CFR 866.5510, within the Immunology review panel as a Class II device.