Clearance Summary
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY received FDA 510(k) clearance under submission number K990916, sponsored by Stellar Bio Systems, 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 1999-04-21.
- Submission: K990916
- Applicant / Sponsor: Stellar Bio Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1999-04-21
Classification & Regulation
This clearance is catalogued under FDA product code KTL and 21 CFR 866.5100, within the Immunology review panel as a Class II device.