510(k) K820683

STAPHYLOCOCCUS LATEX AGGLUTINATION KIT by American Scientific Products — Product Code LHT

K820683 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "STAPHYLOCOCCUS LATEX AGGLUTINATION KIT". The FDA issued a decision of Substantially Equivalent on April 14, 1982. The device falls under product code LHT (Staphylococcus Aureus Somatic Antigens), a Class I device regulated under 21 CFR 866.3700. American Scientific Products has at least 10 other 510(k) clearances on record.