Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS received FDA 510(k) clearance under submission number K063720, 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 2007-04-09.
- Submission: K063720
- Applicant / Sponsor: Ortho-Clinical Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2007-04-09
Classification & Regulation
This clearance is catalogued under FDA product code DHA and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.