FDA 510(k) Applications for Medical Device Product Code "DKJ"
(Colorimetry, Salicylate)

FDA 510(k) Number Applicant Device Name Decision Date
K020794 BAYER DIAGNOSTICS CORP. SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM 07/11/2002
K014173 BECKMAN COULTER, INC. SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR 02/15/2002
K964715 DADE INTL., INC. PARAMAX SALICYLATE REAGENT 04/25/1997
K980032 DIAGNOSTIC CHEMICALS LTD. SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 03/02/1998
K042329 DIAGNOSTIC CHEMICALS LTD. SALICYLATE-SL ASSAY 12/27/2004
K981872 DIAGNOSTIC CHEMICALS LTD. SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 06/29/1998
K961131 DIAGNOSTIC REAGENTS, INC. SALICYLATE ASSAY 04/29/1996
K093939 SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CHEMISTRY SALICYLATE REAGENT 05/19/2010
K011878 SYVA CO. EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL 08/13/2001


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