510(k) K812190

COCCIDIOIDES IMMUNODIFFUSION SYSTEM by American Scientific Products — Product Code GMI

K812190 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "COCCIDIOIDES IMMUNODIFFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on August 31, 1981. The device falls under product code GMI (Antigen, Cf And / Or Id, 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.