510(k) K812591

ULTRA ZYME PLUS GPT, #64956, 65035 & 36 by Harleco — Product Code CKA

K812591 is an FDA 510(k) premarket notification submitted by Harleco for the device "ULTRA ZYME PLUS GPT, #64956, 65035 & 36". The FDA issued a decision of Substantially Equivalent on September 24, 1981. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Harleco has at least 10 other 510(k) clearances on record.