510(k) K994101

E. HISTOLYTICA II by Techlab, Inc. — Product Code KHW

K994101 is an FDA 510(k) premarket notification submitted by Techlab, Inc. for the device "E. HISTOLYTICA II". The FDA issued a decision of Substantially Equivalent on December 21, 1999. The device falls under product code KHW (Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.), a Class II device regulated under 21 CFR 866.3220. Techlab, Inc. has at least 10 other 510(k) clearances on record.