510(k) K042941

DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS by Dade Behring, Inc. — Product Code GIZ

K042941 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS". The FDA issued a decision of Substantially Equivalent on December 2, 2004. The device falls under product code GIZ (Plasma, Control, Normal), a Class II device regulated under 21 CFR 864.5425. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.