510(k) K913371

TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL by Creative Laboratory Products, Inc. — Product Code JIT

K913371 is an FDA 510(k) premarket notification submitted by Creative Laboratory Products, Inc. for the device "TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL". The FDA issued a decision of Substantially Equivalent on November 8, 1991. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Creative Laboratory Products, Inc. has at least 10 other 510(k) clearances on record.