510(k) K821804

RUBELLA RQ BIO-ENZABEAD KIT by Litton Bionetics — Product Code LFX

K821804 is an FDA 510(k) premarket notification submitted by Litton Bionetics for the device "RUBELLA RQ BIO-ENZABEAD KIT". The FDA issued a decision of Substantially Equivalent on September 14, 1982. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Litton Bionetics has at least 10 other 510(k) clearances on record.