510(k) K071247

N LATEX RF KIT by Dade Behring, Inc. — Product Code DHR

K071247 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "N LATEX RF KIT". The FDA issued a decision of Substantially Equivalent on August 8, 2007. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.