FDA 510(k) Applications for Medical Device Product Code "JPI"
(Device, Hematocrit Measuring)

FDA 510(k) Number Applicant Device Name Decision Date
K163342 Abbott Laboratories i-STAT Hematocrit test with i-STAT Alinity System 08/22/2017
K183680 Abbott Point of Care Inc. i-STAT CHEM8+ cartridge with the i-STAT 1 System 02/28/2020


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