510(k) K030067

VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS by Ortho-Clinical Diagnostics — Product Code MJX

K030067 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS". The FDA issued a decision of Substantially Equivalent on January 17, 2003. The device falls under product code MJX (Kit, Serological, Positive Control), a Class I device regulated under 21 CFR 862.1660. Ortho-Clinical Diagnostics has at least 10 other 510(k) clearances on record.