510(k) Report

Devices descending from K983703

4 later devices reach Modification to Abuscreen Online for Methadone through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021505Online Dat II Methadone IIRoche Diagnostics Corp.20023—
+2K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…Roche Diagnostics20260—
+2K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche Diagnostics20260—
+2K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…Roche Diagnostics20220—