510(k) K841434

VARICELLA-ZOSTER(IGG) IFA TEST by Zeus Scientific, Inc. — Product Code GQW

K841434 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "VARICELLA-ZOSTER(IGG) IFA TEST". The FDA issued a decision of Substantially Equivalent on April 19, 1985. The device falls under product code GQW (Antigen, Cf, (Including Cf Control), Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.