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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K182280

ARK Tramadol Assay · Ark Diagnostics, Inc. · decided 2018-12-10 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ARK™ Tramadol Cutoff Calibrator5040-0002-02ARK DIAGNOSTICS INCDLJ00858724003827
DRI Tramadol Cutoff Calibrator KitB40000352ARK DIAGNOSTICS INCDJG00812101031032
DRI Tramadol Assay - 115mLB40000351ARK DIAGNOSTICS INCDJG00812101031018
DRI Tramadol Negative Calibrator KitB40000353ARK DIAGNOSTICS INCDJG00812101031025
DRI Tramadol Assay - 500 mLB40000350ARK DIAGNOSTICS INCDJG00812101031001
DRI Tramadol Control KitB40000354ARK DIAGNOSTICS INCDJG00812101031056
ARK™ Tramadol Negative Calibrator5040-0002-01ARK DIAGNOSTICS INCDLJ00858724003810
ARK™ Tramadol Assay (115mL)5040-0001-01ARK DIAGNOSTICS INCDJG00858724003780
ARK™ Tramadol Control5040-0003-00ARK DIAGNOSTICS INCLAS00858724003834
ARK™ Tramadol Calibrator5040-0002-00ARK DIAGNOSTICS INCDLJ00858724003803
ARK™ Tramadol Assay (500mL)5040-0001-02ARK DIAGNOSTICS INCDJG00858724003797
DRI Tramadol Calibrator KitB40000366ARK DIAGNOSTICS INCDJG00812101031049
ARK™ Tramadol Assay5040-0001-00ARK DIAGNOSTICS INCDJG00858724003773