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

FDA 510(k) Number Applicant Device Name Decision Date
K951290 ABBOTT LABORATORIES AXSYM SALICYLATE 08/08/1995
K844070 ABBOTT LABORATORIES TDX SALICYLATE 11/27/1984
K852027 ADVANCED BIOMEDICAL METHODS, INC. GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER 05/29/1985
K833003 AMERICAN DADE PARAMAX SALICYLATE REAGENT 10/28/1983
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
K813431 BIO-ANALYTICS LABORATORIES, INC. SALICYLATES 03/25/1982
K813185 CLINTECH DIAGNOSTICS CORP. SALICYLATE STAT-PAK 11/24/1981
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
K842158 DIAGNOSTIC CHEMICALS, LTD. (USA) SALICYLATE ASSAY KIT 10/22/1984
K870336 DIAGNOSTIC CHEMICALS, LTD. (USA) SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71 02/20/1987
K961131 DIAGNOSTIC REAGENTS, INC. SALICYLATE ASSAY 04/29/1996
K904301 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD 11/09/1990
K902356 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) 07/16/1990
K873425 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST SALICYLATE (SAL) #16691 10/29/1987
K872321 EM DIAGNOSTIC SYSTEMS, INC. EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 08/28/1987
K872330 EM DIAGNOSTIC SYSTEMS, INC. EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 07/09/1987
K882038 GDS TECHNOLOGY, LLC. GDS ENZYMATIC SALICYLATE REAGENT 06/24/1988
K823523 MARION LABORATORIES, INC. TOXI-LAB RAPID SCREEN 01/14/1983
K831336 QUANTIMETRIX CORP. SALICYLATE ASSAY KIT 07/07/1983
K946000 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE(R) CALIBRATORS 01/25/1995
K843180 SCLAVO, INC. SALICYLATE TEST 09/07/1984
K093939 SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CHEMISTRY SALICYLATE REAGENT 05/19/2010
K840243 SIGMA CHEMICAL CO. DETERMIN. OF SALICYLATE IN SERUM/PLAST 03/23/1984
K861615 STERLING DIAGNOSTICS, INC. SALICYLATE REAGENT SET 05/23/1986
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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