510(k) K875368

THE DDI SERODOT RUBELLA IGG TEST KIT by Disease Detection International, Inc. — Product Code LFX

K875368 is an FDA 510(k) premarket notification submitted by Disease Detection International, Inc. for the device "THE DDI SERODOT RUBELLA IGG TEST KIT". The FDA issued a decision of Substantially Equivalent on March 23, 1988. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Disease Detection International, Inc. has at least 10 other 510(k) clearances on record.