510kDecisions.com

FDA 510(k) Applications for Medical Device Product Code "DMT"
(Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet)

FDA 510(k) Number Applicant Device Name Decision Date
K000410 BECKMAN COULTER, INC. SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS 04/10/2000
K971506 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR 06/03/1997
K843378 DIAGNOSTIC CHEMICALS, LTD. (USA) ETHYL ALCOHOL ASSAY KIT 9/14/1984
K923783 DIAGNOSTIC REAGENTS, INC. ETHYL ALCOHOL ASSAY 1/21/1993
K934273 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) 3/21/1994
K864894 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 1/9/1987
K810467 SYVA CO. EMIT-ST SERUM ETHYL ALCOHOL ASSAY 3/6/1981
K802621 SYVA CO. EMIT-STM ETHYL ALCOHOL ASSAY 10/31/1980


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