510(k) K936145

COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY by Chemicon Intl., Inc. — Product Code GNM

K936145 is an FDA 510(k) premarket notification submitted by Chemicon Intl., Inc. for the device "COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code GNM (Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6), a Class I device regulated under 21 CFR 866.3145. Chemicon Intl., Inc. has at least 7 other 510(k) clearances on record.