510(k) K140393

RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 by Randox Laboratories Limited — Product Code JJY

K140393 is an FDA 510(k) premarket notification submitted by Randox Laboratories Limited for the device "RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3". The FDA issued a decision of Substantially Equivalent on Mar 25, 2014. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Randox Laboratories Limited has at least 10 other 510(k) clearances on record.