510(k) K802404

ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE by Ortho Diagnostics, Inc. — Product Code DCF

K802404 is an FDA 510(k) premarket notification submitted by Ortho Diagnostics, Inc. for the device "ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Ortho Diagnostics, Inc. has at least 10 other 510(k) clearances on record.