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Siemens Healthcare Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 72 products

Total Devices72
Categories49
Latest FDA decision2026-08-10
TypeNumberDevice NameCodeDateActions
510(k) K253528 Atellica IM CA 19-9 IINIG2026-08-10 View
PMA P930027 Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerMTF2026-07-27 View
PMA P010007 KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSLOK2026-07-27 View
510(k) K261364 Atellica CH Acetaminophen 2 (ACTM)LDP2026-07-24 View
PMA P930036 KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSLOK2026-05-11 View
PMA P250026 Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditionsMTG2026-05-11 View
510(k) K251998 Atellica CH Diazo Total Bilirubin (D_TBil)CIG2026-02-27 View
510(k) K251543 Atellica® IM TSH3-Ultra II (TSH3ULII)JLW2026-02-06 View
510(k) K251630 Atellica IM Total PSA II (tPSAII)LTJ2026-01-05 View
510(k) K250816 ADVIA Centaur Anti-Thyroglobulin II (aTgII)JNL2025-12-04 View
PMA P240021 Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerMTF2025-12-03 View
510(k) K250250 ADVIA Centaur Anti-Thyroid Peroxidase IIJZO2025-10-17 View
PMA P100039 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-10-17 View
PMA P200017 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-10-17 View
PMA P210019 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-10-17 View
510(k) K242981 Atellica IM Thyroglobulin (Tg)MSW2025-06-20 View
510(k) K242685 Atellica® CH Creatinine_3 (Crea3)CGX2024-12-04 View
510(k) K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)MRR2024-07-26 View
510(k) K241165 Atellica® IM High-Sensitivity Troponin I (TnIH)MMI2024-07-25 View
510(k) K233050 ADVIA Centaur® TSH3-Ultra II (TSH3ULII)JLW2024-04-04 View

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