510(k) Report

Devices descending from K031990

8 later devices reach Elecsys Precicontrol Troponin T through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092322Elecsys Rubella Igm ImmunoassayRoche Diagnostics20102—
+1K060585Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp.20064—
+2K223867Ids Acth IIImmunodiagnostic Systems Limited20230—
+2K142133Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics20141—
+2K131662Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20130—
+2K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc.201112
+3K163569Elecsys CMV IgMRoche Diagnostics201702
+3K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc.20140—