510(k) K983674

VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS by Ortho-Clinical Diagnostics, Inc. — Product Code JMM

K983674 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS". The FDA issued a decision of Substantially Equivalent on January 29, 1999. The device falls under product code JMM (Column Chromatography & Color Development, Hydroxyproline), a Class I device regulated under 21 CFR 862.1400. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.