Clearance Summary
HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT received FDA 510(k) clearance under submission number K811714, sponsored by Scripps-Miles, 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 1981-07-10.
- Submission: K811714
- Applicant / Sponsor: Scripps-Miles, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1981-07-10
Classification & Regulation
This clearance is catalogued under FDA product code DHN and 21 CFR 866.5100, within the Immunology review panel as a Class II device.