Clearance Summary
MARDX ENA EIA TEST SYSTEM received FDA 510(k) clearance under submission number K946218, sponsored by Hogan & Hartson. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1995-05-15.
- Submission: K946218
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1995-05-15
Classification & Regulation
This clearance is catalogued under FDA product code LJM and 21 CFR 866.5100, within the Immunology review panel as a Class II device.