Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610633

FEI Number

3002806693

Entity Name

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD

City/State/Country

SUDBURY Suffolk, GB

Establishment Address

NORTHERN RD., CHILTON INDUSTRIAL ESTATE, SUDBURY Suffolk CO10 2XQ, GB

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

Expiration Date (Year)

2026

510(k) Number

K002738

PMA Number

N/A

All Registered Proprietary Names

Rapidpoint 500 System Lactate Rapidlab 348 Blood Gas Systems Family Rapidpoint 400/405/500 systems Pleural Fluid RAPIDPOINT 405 RAPIDPOINT 500 Multicap Blood Collection Capillaries Capillary Caps Luer Capillary Blood Gas Blood Collection Capillary Tubes Plastic Capillaries Model 614 M614 M600 Series M600 Rapidlab 1200 Rapidlab Blood Gas Systems Rapidlab 800 Series Rapidlab 1200 Series DCA Systems DCA Vantage 800 SERIES M860 Imidazole Buffer Solution Blood Gas Systems Buffer IMMULITE 2000 Multi-Diluent 2 ADVIA Centaur Multi-Diluent 3 (M-Dil 3) ADVIA Centaur Multi-Diluent 11 (M-Dil 11) Blood Gas Systems 600 Series Blood Gas ADVIA Centaur Multi-Diluent 15 IMMULITE 2000 IgG/IgM Sample Diluent Atellica IM Multi-Diluent 12 (M-Dil 12) Atellica IM Multi-Diluent 13 (M-Dil 13) Atellica IM Multi-Diluent 2 (M-Dil 2) Atellica IM Multi-Diluent 1 (M-Dil 1) Atellica IM Multi-Diluent 10 (M-Dil 10) Atellica IM Multi-Diluent 11 (M-Dil 11) Atellica IM Multi-Diluent 3 (M-Dil 3) Atellica IM Multi-Diluent 15 (M-Dil 15) ADVIA Centaur Multi-Diluent 10 (M-Dil 10) ADVIA Centaur Multi-Diluent 1 (M-Dil 1) Atellica HEMA Diluent (HEMA Diluent) IMMULITE 2000 Multi-Diluent 1 ADVIA Centaur Multi-Diluent 2 (M-Dil 2) MAGIC LITE INTACT PTH DILUENT Ictotest RAPIDPoint® 500e Blood Gas System iCa++ Quick Sampler Rapidpoint 400 Rapidpoint Blood Gas Blood Gas Systems Family

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2012-05-10
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2008-03-28
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2008-03-28
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-03-28
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2008-03-28
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-03-28
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2008-03-28
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2013-05-29
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2011-08-18
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2001-11-15
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2013-01-15
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-01-18
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2008-01-18
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-01-18
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2008-01-18
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2008-01-18
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2008-01-18
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2008-01-18
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2008-01-18
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-01-18
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-01-18
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2008-01-18
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2010-01-27
JCC	Ph Buffer	Pathology	Class 1	864.4010	2001-10-26
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	1998-02-12
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2012-07-26
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2020-03-30
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2020-03-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2020-03-30
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2020-03-30
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2020-03-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2020-03-30
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2020-03-30
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2020-03-30
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2020-03-30
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	1998-06-16
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	1998-06-16
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	1998-06-16
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	1998-06-16
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	1998-06-16
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	1998-06-16
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	1998-06-16

Official Correspondent

No official correspondent registered.

US Agent Details

Felix Akinrinola Business: Siemens Healthcare Diagnostics Inc. Email: felix.akinrinola@siemens-healthineers.com Phone: (781) 8561738

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
3002637618	Siemens Healthcare Diagnostics Inc	East Walpole, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K884771	Instrumentation Laboratory CO	IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY	1989-02-10
K811310	Chem-Elec, Inc.	SODIUM/POTASSIUM REAGENT KITS	1981-07-10
K013373	Roche Diagnostics Corp.	OMNI C ANALYZER	2001-11-02
K760969	Instrumentation Laboratory CO	PH/BLOOD GAS SYSTEM	1977-01-12
K820744	Instrumentation Laboratory CO	IL MODEL 1301, PH BLOOD GAS SYSTEM	1982-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0102-2014	Siemens Healthcare Diagnostics Inc	2	Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Z-0139-2011	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
Z-0038-2008	Radiometer America Inc	2	Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
Z-0778-2007	Instrumentation Laboratory Co.	2	GEM Premier 4000 Laboratory Analyzer
Z-0845-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610633. Last updated year: 2026. Please use registration number 9610633 when referencing this establishment in official correspondence.