Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM received FDA 510(k) clearance under submission number K081543, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2008-10-23.
- Submission: K081543
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1690
- Decision date: 2008-10-23
Classification & Regulation
This clearance is catalogued under FDA product code JLW and 21 CFR 862.1690, within the Clinical Chemistry review panel as a Class II device.