510(k) Report

Devices descending from K935550

4 later devices reach Abuscreen Online Negative Cal/Control Cal Pack and Mil Calibration Pack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974840Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack…Roche Diagnostic Systems, Inc.19983—
+2K013482Abuscreen Online Opiates 300 / 2000Roche Diagnostics Corp.20010—
+2K992890Roche Cobas Integra Opiates 300/2000Roche Diagnostics Corp.19990—
+2K990399Ontrak Testcup M2K, Model Cat. 11 1849 8Roche Diagnostics Corp.19990—