510(k) K872632

DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT by E.I. Dupont DE Nemours & Co., Inc. — Product Code GQN

K872632 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT". The FDA issued a decision of Substantially Equivalent on February 18, 1988. The device falls under product code GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.