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
K893583 BECKMAN BECKMAN CHOLINESTERASE REAGENT KIT 08/15/1989
K103373 BECKMAN COULTER, INC. SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 02/07/2011
K002792 CARESIDE, INC. CARESIDE CHOLINESTERASE 11/08/2000
K912148 CRESTAT DIAGNOSTICS, INC. CHOLINESTERASE TEST KIT 08/12/1991
K955498 DIAGNOSTIC CHEMICALS LTD. CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 01/24/1996
K883890 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD 11/29/1988
K912217 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES 07/01/1991
K913198 EASTMAN KODAK COMPANY KODAK EKTACHEM DT SLIDES (CHE) 08/26/1991
K961656 EQM RESEARCH, INC. TEST-MATE CHE CHOLINESTERASE TEST SYSTEM 11/26/1996
K791725 GILFORD DIAGNOSTICS CHOLINESTERASE REAGENT 10/17/1979
K943367 INSTRUMENTATION LABORATORY CO. IL TEST CHOLINESTERASE 02/05/1996
K863111 J. D. ASSOC. CHOLINESTERASE 09/11/1986
K030045 OLYMPUS AMERICA, INC. OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) 02/21/2003
K862168 REAGENTS APPLICATIONS, INC. RAICHEM CHOLINESTERASE REAGENT 06/27/1986
K061093 ROCHE DIAGNOSTICS CORP. CHOLINESTERASE GEN.2 TEST SYSTEM 07/03/2006
K873496 SCLAVO, INC. ATYPICAL CHOLINESTERASE 01/27/1989
K880199 SCLAVO, INC. CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE 01/27/1989
K880049 SCLAVO, INC. CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE 01/27/1989
K051444 SENTINEL CH. SRL SENTINEL CHOLINESTERASE LIQUID 06/20/2005
K885272 SIGMA CHEMICAL CO. CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE 03/28/1989
K863203 SIGMA DIAGNOSTICS, INC. CHOLINESTERASE (BTC) REAGENT 09/17/1986
K863202 SIGMA DIAGNOSTICS, INC. CHOLINESTERASE (PTC) REAGENT 09/16/1986
K914171 TECH INTL. CO. "IN VITRO" DIAGNOSTIC REGEANT SET,CHOLINESTERASE 12/18/1991
K023992 WIENER LABORATORIES S.A.I.C. WIENER LAB COLINESTERASA AA 02/12/2003


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