Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY received FDA 510(k) clearance under submission number K983507, 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 1998-11-04.
- Submission: K983507
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1998-11-04
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.