510(k) K032296

VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS by Ortho-Clinical Diagnostics, Inc. — Product Code JIS

K032296 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS". The FDA issued a decision of Substantially Equivalent on August 13, 2003. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.