510(k) Report

Devices descending from K924863

15 later devices reach Aia-Pack FSH Calibration Verification Test Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970984The Elecsys Calcheck ProgesteroneBoehringer Mannheim Corp.19970—
+1K970147Elecsys Calcheck ProlactinBoehringer Mannheim Corp.19976—
+1K970146Elecsys Calcheck TestosteroneBoehringer Mannheim Corp.19974—
+1K964830Elecsys Calcheck LHBoehringer Mannheim Corp.19960—
+1K964829Elecsys Calcheck FSHBoehringer Mannheim Corp.19960—
+2K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…Siemens Healthcare Diagnostics, Inc.20143—
+2K053059Roche Diagnostics Elecsys Prolactin II CalcheckRoche Diagnostics20055—
+3K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc.20162—
+3K060585Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp.20064—
+4K223867Ids Acth IIImmunodiagnostic Systems Limited20230—
+4K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc.20190—
+4K190121Ids SHBGImmunodiagnostic Systems, Ltd.20190—
+4K131662Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20130—
+4K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc.201112
+5K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc.20140—