510(k) Report

Devices descending from K991094

3 later devices reach Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020672Elecsys Anti-TG Test SystemRoche Diagnostics Corp.20022—
+2K053426Roche Elecsys Anti-TGRoche Diagnostics Corp.20061—
+3K222610Elecsys Anti-TgRoche Diagnostics20230—