510(k) K191626

Stat Profile Prime ES Comp Plus Analyzer System by Nova Biomedical Corporation — Product Code JFP

K191626 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corporation for the device "Stat Profile Prime ES Comp Plus Analyzer System". The FDA issued a decision of Substantially Equivalent on August 16, 2019. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. Nova Biomedical Corporation has at least 10 other 510(k) clearances on record.