510(k) K864696

ALLERG*ENS ENZYME IMMUNOASSAY KIT by Dexall Biomedical Labs, Inc. — Product Code DHB

K864696 is an FDA 510(k) premarket notification submitted by Dexall Biomedical Labs, Inc. for the device "ALLERG*ENS ENZYME IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on March 17, 1987. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Dexall Biomedical Labs, Inc. has at least 3 other 510(k) clearances on record.