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


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