510(k) Report

Devices descending from K191899

3 later devices reach Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated… through their predicates, nearest generation first.

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