510(k) K843565

KOVA TROL I,II, III HUMAN URINE-DRIED by Icl Scientific — Product Code JJW

K843565 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "KOVA TROL I,II, III HUMAN URINE-DRIED". The FDA issued a decision of Substantially Equivalent on October 5, 1984. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Icl Scientific has at least 10 other 510(k) clearances on record.