FDA 510(k) Applications for Medical Device Product Code "DIH"
(Colorimetry, Cholinesterase)

FDA 510(k) Number Applicant Device Name Decision Date
K001344 BAYER CORP. ADVIA IMS 06/26/2000
K013750 BAYER DIAGNOSTICS CORP. ADVIA 1650 CHOLINESTERASE ASSAY 01/18/2002
K103373 BECKMAN COULTER, INC. SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 02/07/2011
K002792 CARESIDE, INC. CARESIDE CHOLINESTERASE 11/08/2000
K955498 DIAGNOSTIC CHEMICALS LTD. CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 01/24/1996
K961656 EQM RESEARCH, INC. TEST-MATE CHE CHOLINESTERASE TEST SYSTEM 11/26/1996
K943367 INSTRUMENTATION LABORATORY CO. IL TEST CHOLINESTERASE 02/05/1996
K030045 OLYMPUS AMERICA, INC. OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) 02/21/2003
K061093 ROCHE DIAGNOSTICS CORP. CHOLINESTERASE GEN.2 TEST SYSTEM 07/03/2006
K051444 SENTINEL CH. SRL SENTINEL CHOLINESTERASE LIQUID 06/20/2005
K023992 WIENER LABORATORIES S.A.I.C. WIENER LAB COLINESTERASA AA 02/12/2003


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