510(k) K081217

HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM by Hycor Biomedical, Inc. — Product Code DHB

K081217 is an FDA 510(k) premarket notification submitted by Hycor Biomedical, Inc. for the device "HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM". The FDA issued a decision of Substantially Equivalent on May 22, 2008. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Hycor Biomedical, Inc. has at least 10 other 510(k) clearances on record.