510(k) K891382

ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES by Ortho Diagnostic Systems, Inc. — Product Code GQL

K891382 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES". The FDA issued a decision of Substantially Equivalent on June 6, 1989. The device falls under product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.