510(k) K163342

i-STAT Hematocrit test with i-STAT Alinity System by Abbott Laboratories — Product Code JPI

K163342 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "i-STAT Hematocrit test with i-STAT Alinity System". The FDA issued a decision of Substantially Equivalent on August 22, 2017. The device falls under product code JPI (Device, Hematocrit Measuring), a Class II device regulated under 21 CFR 864.6400. Abbott Laboratories has at least 10 other 510(k) clearances on record.