Clearance Summary
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY received FDA 510(k) clearance under submission number K083391, sponsored by Diagnostic Hybrids, 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 2009-05-21.
- Submission: K083391
- Applicant / Sponsor: Diagnostic Hybrids, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5870
- Decision date: 2009-05-21
Classification & Regulation
This clearance is catalogued under FDA product code JZO and 21 CFR 866.5870, within the Immunology review panel as a Class II device.