510(k) K142181

RANDOX ALDOLASE CALIBRATION SERUM by Randox Laboratories Limited — Product Code JIT

K142181 is an FDA 510(k) premarket notification submitted by Randox Laboratories Limited for the device "RANDOX ALDOLASE CALIBRATION SERUM". The FDA issued a decision of Substantially Equivalent on September 18, 2014. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Randox Laboratories Limited has at least 10 other 510(k) clearances on record.