510(k) K812189

COCCIDIOIDES LATEX AGGLUTINATION by American Scientific Products — Product Code GMG

K812189 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "COCCIDIOIDES LATEX AGGLUTINATION". The FDA issued a decision of Substantially Equivalent on August 25, 1981. The device falls under product code GMG (Antigen, Latex Agglutination, Coccidioides Immitis), a Class II device regulated under 21 CFR 866.3135. American Scientific Products has at least 10 other 510(k) clearances on record.