Clearance Summary
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS received FDA 510(k) clearance under submission number K113020, sponsored by Immco Diagnostics, 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 2012-10-25.
- Submission: K113020
- Applicant / Sponsor: Immco Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2012-10-25
Classification & Regulation
This clearance is catalogued under FDA product code MID and 21 CFR 866.5660, within the Immunology review panel as a Class II device.