510(k) K772033

GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* by Harleco — Product Code JMK

K772033 is an FDA 510(k) premarket notification submitted by Harleco for the device "GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*". The FDA issued a decision of Substantially Equivalent on November 17, 1977. The device falls under product code JMK (Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase), a Class I device regulated under 21 CFR 862.1380. Harleco has at least 10 other 510(k) clearances on record.