510(k) K990141

LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 by Light Diagnostics — Product Code GQW

K990141 is an FDA 510(k) premarket notification submitted by Light Diagnostics for the device "LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295". The FDA issued a decision of Substantially Equivalent on October 19, 1999. The device falls under product code GQW (Antigen, Cf, (Including Cf Control), Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Light Diagnostics has at least 10 other 510(k) clearances on record.