510(k) Report

Devices descending from K950090

9 later devices reach Orgentec Anti-Tpo Pia (Pin Immuno Assay) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980206Immulite Anti-TG ABDiagnostic Products Corp.19984—
+1K963695Immulite Anti-Tpo-AB (Lktoi,LKT05,LktozDiagnostic Products Corp.19973—
+2K991096Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06Diagnostic Products Corp.19992—
+2K991094Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6Diagnostic Products Corp.199932
+3K061382Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227Beckman Coulter, Inc.20061—
+3K020672Elecsys Anti-TG Test SystemRoche Diagnostics Corp.20022—
+4K240469Access TPO AntibodyBeckman Coulter, Inc.20240—
+4K053426Roche Elecsys Anti-TGRoche Diagnostics Corp.20061—
+5K222610Elecsys Anti-TgRoche Diagnostics20230—