510(k) Report

Devices descending from K974840

3 later devices reach Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013482Abuscreen Online Opiates 300 / 2000Roche Diagnostics Corp.20010—
+1K992890Roche Cobas Integra Opiates 300/2000Roche Diagnostics Corp.19990—
+1K990399Ontrak Testcup M2K, Model Cat. 11 1849 8Roche Diagnostics Corp.19990—