510(k) K855034

AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT by Bartels Immunodiagnostic Supplies, Inc. — Product Code LIJ

K855034 is an FDA 510(k) premarket notification submitted by Bartels Immunodiagnostic Supplies, Inc. for the device "AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT". The FDA issued a decision of Substantially Equivalent on March 11, 1986. The device falls under product code LIJ (Peroxidase Anti-Peroxidase Immunohistochemical Stain), a Class I device regulated under 21 CFR 864.4400. Bartels Immunodiagnostic Supplies, Inc. has at least 10 other 510(k) clearances on record.