Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS received FDA 510(k) clearance under submission number K011463, sponsored by Ortho-Clinical Diagnostics. 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 2001-06-13.
- Submission: K011463
- Applicant / Sponsor: Ortho-Clinical Diagnostics
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2001-06-13
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.