FDA 510(k) Applications for Medical Device Product Code: JFL (Ph Rate Measurement, Carbon-Dioxide)

FDA 510(k) Applications for Medical Device Product Code "JFL"
(Ph Rate Measurement, Carbon-Dioxide)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K191298	Abbott Point of Care Inc.	i-STAT CHEM8+ cartridge with the i-STAT 1 System	02/07/2020
K014034	BECKMAN COULTER, INC.	MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)	12/18/2001
K040975	GENCHEM, INC.	GENCHEM CO2 ACID REAGENT	12/27/2004
K963005	NOVA BIOMEDICAL CORP.	NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)	08/23/1996
K963541	SIGMA DIAGNOSTICS, INC.	SIGMA DIAGNOSTICS CO2 ACID REAGENT	10/24/1996
K963538	SIGMA DIAGNOSTICS, INC.	SIGMA DIAGNOSTICS CO2ALKALINE BUFFER	10/11/1996
K963540	SIGMA DIAGNOSTICS, INC.	SIGMA DIAGNOSTICS ELECTROLYTE BUFFER	09/27/1996