510(k) Report

Devices descending from K060585

4 later devices reach Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223867Ids Acth IIImmunodiagnostic Systems Limited20230—
+1K131662Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20130—
+1K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc.201112
+2K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc.20140—