510(k) K864663

PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code LJP

K864663 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 2, 1987. The device falls under product code LJP (Antiserum, Fluorescent, Chlamydia Trachomatis), a Class I device regulated under 21 CFR 866.3120. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.