FDA 510(k) Applications for Medical Device Product Code "JFP"
(Electrode, Ion Specific, Calcium)

FDA 510(k) Number Applicant Device Name Decision Date
K191360 Abbott Point of Care, Inc. i-STAT CHEM8+ cartridge with the i-STAT 1 System 02/14/2020
K961458 AVL SCIENTIFIC CORP. AVL 9180 ELECTROLYTE ANALYZER 06/12/1996
K972673 AVL SCIENTIFIC CORP. AVL 9181 ELECTROLYTE ANALYZER 08/20/1997
K984299 AVL SCIENTIFIC CORP. AVL OPTI CRITICAL CARE ANALYZER 12/11/1998
K963694 MEDICA CORP. EASYLYTE CALCIUM/CHLORIDE ANALYZER 11/27/1996
K152327 Medica Corporation EasyLyte Na/K/Cl/Ca Analyzer 12/01/2016
K960120 NOVA BIOMEDICAL CORP. STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS 03/11/1996
K191626 Nova Biomedical Corporation Stat Profile Prime ES Comp Plus Analyzer System 08/16/2019


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