Medical Device Manufacturer · US , New York , NY

Siemens Healthcare Diagnostics, Inc.

152 submissions · 151 cleared · Since 2008
152
Total
151
Cleared
1
Denied

Siemens Healthcare Diagnostics, Inc. — FDA 510(k) Submissions

Siemens Healthcare Diagnostics, Inc. has submitted 152 FDA 510(k) premarket notifications since 2008, of which 151 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), Radioimmunoassay, Thyroid-stimulating Hormone, Calibrator, Multi-analyte Mixture, Immunoassay Method, Troponin Subunit, Calibrator, Secondary . Use the specialty filter in the sidebar to narrow results.

152 devices
1–25 of 152
Atellica CH Diazo Total Bilirubin (D_TBil)
K251998 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Feb 2026 245d
Atellica? IM TSH3-Ultra II (TSH3ULII)
K251543 · JLW Radioimmunoassay,... · Chemistry
Feb 2026 262d
Atellica IM Total PSA II (tPSAII)
K251630 · LTJ Prostate-specific Antigen... · Immunology
Jan 2026 222d
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
K250816 · JNL Immunochemical,... · Immunology
Dec 2025 261d
ADVIA Centaur Anti-Thyroid Peroxidase II
K250250 · JZO System, Test, Thyroid... · Immunology
Oct 2025 262d
Atellica IM Thyroglobulin (Tg)
K242981 · MSW System, Test, Thyroglobulin · Immunology
Jun 2025 267d
Atellica? CH Creatinine_3 (Crea3)
K242685 · CGX Alkaline Picrate,... · Chemistry
Dec 2024 89d
Atellica? CH HDL Cholesterol (HDLC)& Atellica? CH LDL Cholesterol (LDLC)
K241800 · MRR System, Test, Low... · Chemistry
Jul 2024 35d
Atellica? IM High-Sensitivity Troponin I (TnIH)
K241165 · MMI Immunoassay Method,... · Chemistry
Jul 2024 90d
ADVIA Centaur? TSH3-Ultra II (TSH3ULII)
K233050 · JLW Radioimmunoassay,... · Chemistry
Apr 2024 192d
Atellica? CH High Sensitivity C-Reactive Protein 2 (hCRP2)
K233242 · NQD Cardiac C-reactive... · Chemistry
Jan 2024 112d
ADVIA Centaur? NT-proBNPII (PBNPII)
K220265 · NBC Test, Natriuretic Peptide · Chemistry
Sep 2023 601d
Atellica? CH Phencyclidine (Pcp), Atellica? CH Vancomycin (Vanc)
K222439 · LEH Radioimmunoassay, Vancomycin · Toxicology
Aug 2023 361d
Emit? II Plus Buprenorphine Assay
K221605 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jul 2023 418d
A-LYTE? Integrated Multisensor (IMT Na K Cl)
K222438 · JGS Electrode, Ion Specific,... · Chemistry
Jul 2023 347d
Atellica? CI Analyzer, Atellica? IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica? CH Albumin BCP (AlbP)
K222116 · JLW Radioimmunoassay,... · Chemistry
Jul 2023 360d
Atellica? CH Diazo Direct Bilirubin (D_DBil)
K223078 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jun 2023 255d
ADVIA Centaur? Anti-M?llerian Hormone (AMH)
K221801 · PQO Anti-m?llerian Hormone... · Toxicology
Jun 2023 346d
Atellica? CH Diazo Total Bilirubin (D_TBil)
K222104 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Mar 2023 245d
RCRP Flex reagent cartridge
K221119 · DCN System, Test, C-reactive... · Immunology
Mar 2023 333d
Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
K220262 · PRI Procalcitonin Assay · Microbiology
Aug 2022 207d
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223 · JFY Enzymatic Method, Creatinine · Chemistry
Nov 2021 131d
ADVIA Centaur Enhanced Liver Fibrosis (ELF)
DEN190056 · QQB Prognostic Test For... · Chemistry
Aug 2021 603d
ADVIA Centaur? Digoxin assay
K193397 · KXT Enzyme Immunoassay, Digoxin · Toxicology
Jul 2021 588d
ADVIA Centaur? Total hCG assay
K200210 · DHA System, Test, Human... · Chemistry
Jul 2021 532d

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