510(k) K904761

P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT by Instrumentation Laboratory CO — Product Code CIE

K904761 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT". The FDA issued a decision of Substantially Equivalent on November 20, 1990. The device falls under product code CIE (Volumetric/Manometric, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.