510(k) K852889

GENERAL DIAGNOSTICS RAPID E. COLI TEST by Warner-Lambert Co. — Product Code JTO

K852889 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "GENERAL DIAGNOSTICS RAPID E. COLI TEST". The FDA issued a decision of Substantially Equivalent on July 23, 1985. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.