Clearance Summary
ANA LATEX SLIDE TEST received FDA 510(k) clearance under submission number K800605, sponsored by Biologics Intl., 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 1980-04-02.
- Submission: K800605
- Applicant / Sponsor: Biologics Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5820
- Decision date: 1980-04-02
Classification & Regulation
This clearance is catalogued under FDA product code DHC and 21 CFR 866.5820, within the Immunology review panel as a Class II device.