510(k) K902661

BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 by Baxter Healthcare Corp — Product Code GQL

K902661 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2". The FDA issued a decision of Substantially Equivalent on July 31, 1990. The device falls under product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.