Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Atellica IM CA 19-9 II, Atellica CH Acetaminophen 2 (ACTM), Atellica CH Diazo Total Bilirubin (D_TBil)
154
Total
153
Cleared
1
Denied
FDA 510(k) Regulatory Record - Siemens Healthcare Diagnostics, Inc. Chemistry ✕
96 devices
Cleared
Jul 24, 2026
Atellica CH Acetaminophen 2 (ACTM)
Chemistry
88d
Cleared
Feb 27, 2026
Atellica CH Diazo Total Bilirubin (D_TBil)
Chemistry
245d
Cleared
Feb 06, 2026
Atellica® IM TSH3-Ultra II (TSH3ULII)
Chemistry
262d
Cleared
Dec 04, 2024
Atellica® CH Creatinine_3 (Crea3)
Chemistry
89d
Cleared
Jul 26, 2024
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
Chemistry
35d
Cleared
Jul 25, 2024
Atellica® IM High-Sensitivity Troponin I (TnIH)
Chemistry
90d
Cleared
Apr 04, 2024
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
Chemistry
192d
Cleared
Jan 18, 2024
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
Chemistry
112d
Cleared
Sep 24, 2023
ADVIA Centaur® NT-proBNPII (PBNPII)
Chemistry
601d
Cleared
Jul 25, 2023
A-LYTE® Integrated Multisensor (IMT Na K Cl)
Chemistry
347d
Cleared
Jul 13, 2023
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra...
Chemistry
360d
Cleared
Jun 12, 2023
Atellica® CH Diazo Direct Bilirubin (D_DBil)
Chemistry
255d
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