Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS received FDA 510(k) clearance under submission number K022901, 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 2002-09-27.
- Submission: K022901
- Applicant / Sponsor: Ortho-Clinical Diagnostics
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2002-09-27
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.