510(k) K881932

ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT by Ortho Diagnostic Systems, Inc. — Product Code GQH

K881932 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT". The FDA issued a decision of Substantially Equivalent on August 1, 1988. The device falls under product code GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.