510(k) Report

Devices descending from K970147

6 later devices reach Elecsys Calcheck Prolactin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053059Roche Diagnostics Elecsys Prolactin II CalcheckRoche Diagnostics20055—
+2K060585Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp.20064—
+3K223867Ids Acth IIImmunodiagnostic Systems Limited20230—
+3K131662Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20130—
+3K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc.201112
+4K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc.20140—