Siemens Healthcare Diagnostics Manufacturing Ltd.

FDA Device Registration & Listing · SWORDS Dublin, IE · Registration 8020888

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8020888
FEI Number
3007019572
Entity Name
Siemens Healthcare Diagnostics Manufacturing Ltd.
City/State/Country
SWORDS Dublin, IE
Establishment Address
CHAPEL LANE, SWORDS Dublin --, IE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SIEMENS HEALTHCARE DIAGNOSTICS INC. (Owner Number: 9096044)
Owner / Operator Contact Address
Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue, Tarrytown, NY 10591, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K012904
PMA Number
N/A

All Registered Proprietary Names

ADVIA Hematology 2120i RoHS/REACH instruments ADVIA Centaur Analyzer, ADVIA Centaur Classic Atellica IM 1600 Analyzer Atellica IM Cleaner Atellica IM Wash Atellica IM Acid/Base Atellica IM 1300 Analyzer Atellica IM Acid Atellica IM Ancillary Seal Kit Atellica IM Base Atellica IM 1300 Analyzer (Fully Refurbished) Atellica IM 1600 Analyzer (Fully Refurbished) Atellica IM Total Triiodothyronine (T3) Atellica IM Total Triiodothyronine Diluent (T3 DIL) ADVIA Centaur Total Triiodothyronine Diluent (T3 DIL) ADVIA Centaur Acid and Base Reagents ADVIA Centaur Total Triiodothyronine (T3) ADVIA Centaur XP Analyzer ADVIA Centaur Total Triiodothyronine Master Curve Material (T3 MCM) Atellica IM Total Triiodothyronine Master Curve Material (T3 MCM) ADVIA Centaur CP Analyzer Atellica IM Probe Wash 3 (PW3) POCcelerator UniPOC CentraLink RAPIDComm Atellica Data Manager (ADM) Atellica® Connect SE Atellica® Connect EDM eDM Lite ADVIA 120/2120 ADVIA Centaur XPT System ADVIA 120 Atellica CH IMT Standard A (IMT Standard A) Atellica CH Reagent Probe Cleaner 1 (RPC1) Atellica CH 930 Analyzer Atellica CH Cleaner Atellica CH EMPTY Atellica CH Reagent Probe Cleaner 4 (RPC4) Atellica CH Lamp Coolant (LC) Atellica CH IMT Standard B + Salt Bridge (IMT Standard B + Salt Bridge) Atellica CH Water Bath Additive (WBA) Atellica CH IMT Diluent (IMT Diluent) Atellica Direct Load Atellica CH Reagent Probe Cleaner 2 (RPC2) Atellica CH Diluent Atellica CH IMT Dilution Check (IMT Dilution Check) Atellica CH Check Reagent (CHK) Atellica CH Albumin BCP Calibrator (AlbP CAL) Atellica CH Wash Atellica CH Conditioner Atellica CH EMPTY1 Atellica CH HA1c_E High Volume Labels (50) Atellica CH EMPTY2 Atellica CH HA1c_E High Volume Bottles (5) Atellica CH HA1c_E High Volume Conversion Kit Atellica CH Lid Keying Feature Atellica CH 930 Analyzer (Fully Refurbished) ADVIA 120

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2017-08-22
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-01-02
DHX System, Test, Carcinoembryonic Antigen Immunology Class 2 866.6010 2008-01-02
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2008-01-02
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2008-01-02
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2008-01-02
LOQ Device, General Purpose, Hematology Immunology Class 2 866.6010 2008-01-02
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2008-01-02
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2008-01-02
NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer Immunology Class 2 866.6010 2008-01-02
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2008-01-02
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2008-01-02
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2008-01-02
DBF Ferritin, Antigen, Antiserum, Control Immunology Class 2 866.5340 2008-01-02
CGN Acid, Folic, Radioimmunoassay Clinical Chemistry Class 2 862.1295 2008-01-02
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2008-01-02
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2008-01-02
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-01-02
DGC Ige, Antigen, Antiserum, Control Immunology Class 2 866.5510 2008-01-02
MOI System, Test, Immunological, Antigen, Tumor Immunology Class 2 866.6010 2008-01-02
JFT Fluorometric, Cortisol Clinical Chemistry Class 2 862.1205 2008-01-02
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology Class 2 866.6010 2008-01-02
LGS Fluorescence Polarization Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2008-01-02
LFM Enzyme Immunoassay, Digitoxin Clinical Toxicology Class 2 862.3300 2008-01-02
LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) Immunology Class 2 866.6010 2008-01-02
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2008-01-02
LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) Clinical Toxicology Class 2 862.3350 2008-01-02
LCD Enzyme Immunoassay, Gentamicin Clinical Toxicology Class 2 862.3450 2008-01-02
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2008-01-02
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 2008-01-02
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2008-01-02
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2008-01-02
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2008-01-02
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2008-01-02
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2008-01-02
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2008-01-02
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-01-02
LCR Fluorescent Immunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2008-01-02
GWG Endoscope, Neurological Neurology Class 2 882.1480 2008-01-02
LPS Urinary Homocystine (Nonquantitative) Test System Clinical Chemistry Class 2 862.1377 2008-01-02
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2008-01-02
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2008-01-02
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2017-06-16
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2017-06-16
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2017-06-16
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2008-01-02
DGC Ige, Antigen, Antiserum, Control Immunology Class 2 866.5510 2008-01-02
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-01-02
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2008-01-02
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2008-01-02
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2008-01-02
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2008-01-02
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2008-01-02
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-01-02
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2008-01-02
CGN Acid, Folic, Radioimmunoassay Clinical Chemistry Class 2 862.1295 2008-01-02
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2008-01-02
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2008-01-02
CEW Radioimmunoassay, Parathyroid Hormone Clinical Chemistry Class 2 862.1545 2008-01-02
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2008-01-02
LGS Fluorescence Polarization Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2008-01-02
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2008-01-02
LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) Clinical Toxicology Class 2 862.3350 2008-01-02
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2008-01-02
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2008-01-02
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-01-02
LPS Urinary Homocystine (Nonquantitative) Test System Clinical Chemistry Class 2 862.1377 2008-01-02
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2008-01-02
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2008-01-02
LCR Fluorescent Immunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2008-01-02
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2008-01-02
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2008-01-02
LCD Enzyme Immunoassay, Gentamicin Clinical Toxicology Class 2 862.3450 2008-01-02
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2008-01-02
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2000-02-07
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2012-08-02
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2015-04-27
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2015-04-27
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2011-04-11
GKL Counter, Cell, Automated (Particle Counter) Hematology Class 2 864.5200 2011-04-11
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2017-05-16
CJW Bromcresol Purple Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2017-05-16
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2017-05-16
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2017-05-16
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2017-05-16
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2017-05-16
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2017-05-16
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2008-01-07

Official Correspondent

No official correspondent registered.

US Agent Details

Mary Seeger Business: SIEMENS HEALTHCARE DIAGNOSTICS INC. Email: mary.seeger@siemens-healthineers.com Phone: (914) 3254329

Related Public Records

Same Entity

SIEMENS HEALTHCARE DIAGNOSTICS INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012817228 Epocal Inc Ottawa Ontario, CA
3011194542 Siemens Healthcare GmbH Berlin, DE
3009448641 Siemens Healthcare Diagnostics, Inc. Mishawaka, IN, US
3004959793 EPOCAL, INC. Ottawa Ontario, CA
9610633 SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD SUDBURY Suffolk, GB

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K910283 Danam Electronics DANAM DATACELL-18 1991-04-12
K102064 Becton, Dickinson & CO BD FACS SAMPLE PREP ASSISTANT III (SPA III) 2011-03-07
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-05 ABX Diagnostics Inc 2
Automated Differential Cell Counter
Z-0003-05 ABX Diagnostics Inc 2
Automated Differential Cell Counter
Z-0011-2014 Siemens Healthcare Diagnostics 2
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013 Beckman Coulter Inc. 2
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013 Beckman Coulter Inc. 2
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020888. Last updated year: 2026. Please use registration number 8020888 when referencing this establishment in official correspondence.
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