Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS received FDA 510(k) clearance under submission number K033300, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2003-11-05.
- Submission: K033300
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5680
- Decision date: 2003-11-05
Classification & Regulation
This clearance is catalogued under FDA product code DDR and 21 CFR 866.5680, within the Immunology review panel as a Class II device.