Clearance Summary
ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA received FDA 510(k) clearance under submission number K162788, 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 2017-06-19.
- Submission: K162788
- Applicant / Sponsor: Immco Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2017-06-19
Classification & Regulation
This clearance is catalogued under FDA product code MSV and 21 CFR 866.5660, within the Immunology review panel as a Class II device.