510(k) K043546

DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE by Dade Behring, Inc. — Product Code CDT

K043546 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE". The FDA issued a decision of Substantially Equivalent on January 18, 2005. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.