510(k) K000238

HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G by Mrl Diagnostics — Product Code LGC

K000238 is an FDA 510(k) premarket notification submitted by Mrl Diagnostics for the device "HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G". The FDA issued a decision of Substantially Equivalent on April 14, 2000. The device falls under product code LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific), a Class II device regulated under 21 CFR 866.3305. Mrl Diagnostics has at least 6 other 510(k) clearances on record.