Clearance Summary
ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT received FDA 510(k) clearance under submission number K940588, sponsored by Helix 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 1994-04-20.
- Submission: K940588
- Applicant / Sponsor: Helix Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1994-04-20
Classification & Regulation
This clearance is catalogued under FDA product code LKO and 21 CFR 866.5100, within the Immunology review panel as a Class II device.