Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY received FDA 510(k) clearance under submission number K983990, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1998-12-29.
- Submission: K983990
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1205
- Decision date: 1998-12-29
Classification & Regulation
This clearance is catalogued under FDA product code CGR and 21 CFR 862.1205, within the Clinical Chemistry review panel as a Class II device.