510(k) K990251

DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 by Dade Behring, Inc. — Product Code LFM

K990251 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DGTX FLEX REAGENT CARTRIDGE, MODEL DF36". The FDA issued a decision of Substantially Equivalent on March 31, 1999. The device falls under product code LFM (Enzyme Immunoassay, Digitoxin), a Class II device regulated under 21 CFR 862.3300. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.