FDA 510(k) Applications for Medical Device Product Code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)

FDA 510(k) Applications for Medical Device Product Code "JJF"
(Analyzer, Chemistry, Micro, For Clinical Use)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K040332	ARKRAY, INC.	POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER	06/16/2004
K993634	CARESIDE, INC.	CARESIDE ANALYZER	12/02/1999
K965103	DIAGNOSTIC PRODUCTS CORP.	WINMAX SOFTWARE SYSTEMS	05/09/1997
K973177	DIAMEDIX CORP.	MAGO AUTOMATED EIA PROCESSOR	10/09/1997
K052794	DIASORIN, INC.	ETI-MAX 3000	03/31/2006
K980056	EXIGENT DIAGNOSTICS, INC.	CARESIDE ANALYZER	03/06/1998
K964409	HCL LABORATORY SYSTEMS, INC.	HCL - 200 BIOCHEMISTRY ANALYZER	01/22/1997
K013654	PRECISION SYSTEMS, INC.	PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER	06/05/2002
K033734	ROCHE DIAGNOSTICS CORP.	LIGHTCYCLER INSTRUMENT VERSION 1.2	12/17/2003
K964506	ROCHE MOLECULAR SYSTEMS, INC.	ROCHE COBAS AMPLICOR ANALYZER	05/21/1997
K012966	ROCHE MOLECULAR SYSTEMS, INC.	ROCHE COBAS TAQMAN ANALYZER	02/01/2002
K961209	SEAC S.R.L.	BRIO AUTOMATIC SAMPLINC UNIT	12/24/1996
K971491	SYNERMED, INC.	SYNERMED IR 200 CHEMISTRY ANALYZER	06/26/1997
K973628	VITAL SCIENTIFIC N.V.	VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA	03/13/1998