Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA received FDA 510(k) clearance under submission number K001266, 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 2000-05-02.
- Submission: K001266
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1295
- Decision date: 2000-05-02
Classification & Regulation
This clearance is catalogued under FDA product code CGN and 21 CFR 862.1295, within the Clinical Chemistry review panel as a Class II device.