510(k) K885269

ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS by Dexall Biomedical Labs, Inc. — Product Code DHB

K885269 is an FDA 510(k) premarket notification submitted by Dexall Biomedical Labs, Inc. for the device "ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS". The FDA issued a decision of Substantially Equivalent on February 7, 1989. 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.