510(k) K896852

VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY by Ventrex Laboratories, Inc. — Product Code DHB

K896852 is an FDA 510(k) premarket notification submitted by Ventrex Laboratories, Inc. for the device "VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on December 18, 1989. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Ventrex Laboratories, Inc. has at least 10 other 510(k) clearances on record.