Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS received FDA 510(k) clearance under submission number K032296, 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 2003-08-13.
- Submission: K032296
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2003-08-13
Classification & Regulation
This clearance is catalogued under FDA product code JIS and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.