510(k) K830870

POLYCHACO INDIRECT HEMAGGLUTINATION by Parasitic Disease Consultants — Product Code GMM

K830870 is an FDA 510(k) premarket notification submitted by Parasitic Disease Consultants for the device "POLYCHACO INDIRECT HEMAGGLUTINATION". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code GMM (Antigens, Iha, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Parasitic Disease Consultants has at least 2 other 510(k) clearances on record.