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DNN — Calibrators, Ethyl Alcohol Class II

FDA Device Classification

Classification Details

Product Code
DNN
Device Class
Class II
Regulation Number
862.3200
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K990516emd chemicalsETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSMarch 31, 1999
K973054emd chemicalsETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSOctober 1, 1997
K924733diagnostic reagentsETHYL ALCOHOL CALIBRATORS & CONTROLDecember 9, 1992
K882117verichem laboratoriesETHYL ALCOHOL STANDARDAugust 4, 1988
K853532diagnostic systemsALCOHOL CALIBRATORSSeptember 16, 1985
K810466syvaETHYL ALCOHOL SERUM CALIBRATORMarch 6, 1981
K802620syvaEMIT-STM ETHYL ALCOHOL URINE CALIBRATOROctober 31, 1980