Clearance Summary
STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance under submission number K871972, sponsored by American Dade. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1987-07-21.
- Submission: K871972
- Applicant / Sponsor: American Dade
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 1987-07-21
Classification & Regulation
This clearance is catalogued under FDA product code DGE and 21 CFR 866.5510, within the Immunology review panel as a Class II device.