510(k) Report

Devices descending from K900779

15 later devices reach Enzymun Test (R) LH through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964694Elecsys LH AssayBoehringer Mannheim Corp.199714—
+2K031299Elecsys LH Calset IIRoche Diagnostics Corp.200313—
+3K033873Elecsys C-Peptide CalsetRoche Diagnostics Corp.200412—
+4K103221Elecys HGH Calset, Elecsys HGH Calcheck 5Roche Diagnostics201010—
+4K052002Iron StandardRoche Diagnostics Corp.20050—
+5K122141Ids-Isys Igf-I Calibration VerifiersImmunodiagnostic Systems, Ltd.20120—
+5K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+6K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+6K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+7K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+7K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+7K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+7K170938CalSet IGF-1Roche Diagnostics20170—
+7K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+8K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—