510(k) K000566

MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS by Ortho-Clinical Diagnostics, Inc. — Product Code LTJ

K000566 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS". The FDA issued a decision of Substantially Equivalent on March 9, 2000. The device falls under product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers), a Class II device regulated under 21 CFR 866.6010. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.