510(k) K012518

TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 by Thermo Dma, Inc. — Product Code CJE

K012518 is an FDA 510(k) premarket notification submitted by Thermo Dma, Inc. for the device "TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113". The FDA issued a decision of Substantially Equivalent on October 9, 2001. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Thermo Dma, Inc. has at least 3 other 510(k) clearances on record.