510(k) K771474

MULTISTAT III X-HBDH TEST by Instrumentation Laboratory CO — Product Code JMK

K771474 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "MULTISTAT III X-HBDH TEST". The FDA issued a decision of Substantially Equivalent on September 13, 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. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.