FDA 510(k) Applications for Medical Device Product Code: JIF (Enzymatic Method, Ammonia)

FDA 510(k) Applications for Medical Device Product Code "JIF"
(Enzymatic Method, Ammonia)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K981467	ABBOTT LABORATORIES	AMM	06/22/1998
K981920	ABBOTT LABORATORIES	AMM	07/22/1998
K023841	BAYER DIAGNOSTICS CORP.	AMMONIA ASSAY FOR THE ADVIA 1650	12/24/2002
K021151	BAYER DIAGNOSTICS CORP.	AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	07/13/2002
K984402	BECKMAN COULTER, INC.	SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT	01/29/1999
K003196	BECKMAN COULTER, INC.	SYNCHRON SYSTEMS AMMONIA REAGENT	12/22/2000
K062316	DADE BEHRING, INC.	DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE	09/06/2006
K964565	DADE INTL., INC.	PARAMAX AMMONIA AND AMMONIA BLANK REAGENT	11/22/1996
K033921	DIAGNOSTIC CHEMICALS LTD.	AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10	03/10/2004
K001285	DIAGNOSTIC CHEMICALS LTD.	AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30	06/02/2000
K030873	RANDOX LABORATORIES, LTD.	RANDOX AMMONIA	05/12/2003
K183517	Roche Diagnostics Operations (RDO)	Ammonia II	02/08/2019
K051114	SENTINEL CH. SRL	SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY	11/25/2005
K123320	SIEMENS HEALTHCARE DIAGNOSTICS	DIMENSION AMMONIA FLEX REAGENT CARTRIDGE	02/15/2013
K123677	SIEMENS HEALTHCARE DIAGNOSTICS	DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)	03/07/2013
K974620	TRACE AMERICA, INC.	AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)	01/02/1998