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Siemens Healthcare Diagnostics Products, Ltd.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories4
Latest FDA decision2025-09-18
TypeNumberDevice NameCodeDateActions
PMA P010050 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-09-18 View
PMA P010052 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-09-18 View
PMA P010051 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-08-04 View
510(k) K233946 IMMULITE® 2000 BR-MAMOI2024-03-13 View
510(k) K213510 IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MALTK2023-09-08 View
PMA P010053 Unknown Device2023-08-30 View
510(k) K202826 IMMULITE® 2000 CortisolCGR2021-01-15 View
510(k) K203270 IMMULITE/IMMULITE® 1000 CortisolCGR2021-01-15 View
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