Clearance Summary
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT received FDA 510(k) clearance under submission number K101921, sponsored by Ortho-Clinical Diagnostics. 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 2010-10-22.
- Submission: K101921
- Applicant / Sponsor: Ortho-Clinical Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1545
- Decision date: 2010-10-22
Classification & Regulation
This clearance is catalogued under FDA product code CEW and 21 CFR 862.1545, within the Clinical Chemistry review panel as a Class II device.