510(k) K973054

ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS by Emd Chemicals, Inc. — Product Code DNN

K973054 is an FDA 510(k) premarket notification submitted by Emd Chemicals, Inc. for the device "ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS". The FDA issued a decision of Substantially Equivalent on October 1, 1997. The device falls under product code DNN (Calibrators, Ethyl Alcohol), a Class II device regulated under 21 CFR 862.3200. Emd Chemicals, Inc. has at least 10 other 510(k) clearances on record.