510(k) K061251

DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR by Dade Behring, Inc. — Product Code JIS

K061251 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR". The FDA issued a decision of Substantially Equivalent on May 31, 2006. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.