510(k) K991787

N LATEX IGE MONO REAGENT by Dade Behring, Inc. — Product Code DGC

K991787 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "N LATEX IGE MONO REAGENT". The FDA issued a decision of Substantially Equivalent on July 7, 1999. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.