FDA 510(k) Applications for Medical Device Product Code "DNN"
(Calibrators, Ethyl Alcohol)

FDA 510(k) Number Applicant Device Name Decision Date
K924733 DIAGNOSTIC REAGENTS, INC. ETHYL ALCOHOL CALIBRATORS & CONTROL 12/09/1992
K853532 DIAGNOSTIC SYSTEMS ALCOHOL CALIBRATORS 09/16/1985
K973054 EMD CHEMICALS INC. ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS 10/01/1997
K990516 EMD CHEMICALS INC. ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS 03/31/1999
K802620 SYVA CO. EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR 10/31/1980
K810466 SYVA CO. ETHYL ALCOHOL SERUM CALIBRATOR 03/06/1981
K882117 VERICHEM LABORATORIES, INC. ETHYL ALCOHOL STANDARD 08/04/1988


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