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Data / Medical devices / United Kingdom / Siemens Healthcare Diagnostics Manufacturing Ltd

Siemens Healthcare Diagnostics Manufacturing Ltd: FDA-registered device maker in SUDBURY Suffolk, United Kingdom, 14 510(k) clearances

Siemens Healthcare Diagnostics Manufacturing Ltd is registered with the FDA (registration 9610633) in SUDBURY Suffolk, United Kingdom. It lists 30 device types. The FDA files 14 510(k) clearances under its listings, the newest dated March 27, 2020. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Siemens Healthcare Diagnostics Manufacturing Ltd
FDA registration number
9610633
FEI number
3002806693
Address
Northern RD. Chilton Industrial Estate, SUDBURY Suffolk, United Kingdom, CO10 2XQ
Owner or operator
SIEMENS HEALTHCARE DIAGNOSTICS INC. (9096044)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
February 12, 1998
Registered through
2026
Brand names listed
248 BG System, 600 Series Blood Gas, 800 SERIES, ADVIA Centaur Multi-Diluent 1 (M-Dil 1), ADVIA Centaur Multi-Diluent 10 (M-Dil 10), ADVIA Centaur Multi-Diluent 11 (M-Dil 11), ADVIA Centaur Multi-Diluent 15, ADVIA Centaur Multi-Diluent 2 (M-Dil 2) and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, Lactic, Enzymatic MethodKHP1Manufactureraccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Manufactureraccessdata.fda.gov
Assay, Glycosylated HemoglobinLCP2Manufactureraccessdata.fda.gov
Automated Urinalysis SystemKQO1Manufactureraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Manufacturer, Specification developeraccessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test SystemMQM1Manufactureraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Manufactureraccessdata.fda.gov
Blood, Occult, Enzymatic Method, In UrineJIP2Manufactureraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Manufactureraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Manufactureraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Manufactureraccessdata.fda.gov
Diluent, Blood CellGIF1Manufactureraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Manufactureraccessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhCHL2Manufacturer, Specification developeraccessdata.fda.gov
Electrode, Ion Specific, CalciumJFP2Manufacturer, Specification developeraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Manufacturer, Specification developeraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Manufacturer, Specification developeraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Manufacturer, Specification developeraccessdata.fda.gov
Enzymatic Method, CreatinineJFY2Manufactureraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Manufactureraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Manufactureraccessdata.fda.gov
Instrument, Hematocrit, AutomatedGKF2Manufacturer, Specification developeraccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Manufactureraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Manufactureraccessdata.fda.gov
Ph BufferJCC1Manufactureraccessdata.fda.gov
Refractometer For Clinical UseJRE1Manufactureraccessdata.fda.gov
System, Hemoglobin, AutomatedGKR2Manufactureraccessdata.fda.gov
Test, Urine LeukocyteLJX1Manufactureraccessdata.fda.gov
Tube, Collection, Capillary BloodGIO1Repackager or relabeleraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 27, 2020K192240RAPIDPoint 500e Blood Gas SystemCHLSubstantially EquivalentSiemens Healthcare Diagnostics, Inc.accessdata.fda.gov
November 17, 2014K140717CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KITKQOSubstantially EquivalentSiemens Healthcare Diagnosticsaccessdata.fda.gov
April 19, 2013K122539MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEMCHLSubstantially EquivalentSiemens Healthcare Diagnosticsaccessdata.fda.gov
May 3, 2012K113216RAPIDPOINT 500 BLOOD GAS ANALYERKHPSubstantially EquivalentSiemens Healthcare Diagnosticsaccessdata.fda.gov
August 15, 2011K110277RAPIDPOINT 405 NEONATAL BILIRUBINMQMSubstantially EquivalentSiemens Healthcare Diagnosticsaccessdata.fda.gov
October 9, 2009K091216CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797JILSubstantially EquivalentSiemens Healthcare Diagnosticsaccessdata.fda.gov
October 9, 2007K071466DCA VANTAGE, MODEL 5075LCPSubstantially EquivalentSiemens Medical Solutions Diagnosticsaccessdata.fda.gov
December 17, 2003K031560BAYER RAPIDLAB 1200 SYSTEMCHLSubstantially EquivalentBayer Healthcare, LLCaccessdata.fda.gov
July 17, 2002K020616BAYER RAPIDPOINT 405 SYSTEMGKRSubstantially EquivalentBayer Diagnostics Corp.accessdata.fda.gov
December 19, 2000K002738BAYER RAPIDPOINT 400 SYSTEMCHLSubstantially EquivalentBayer Corp.accessdata.fda.gov
June 24, 1996K962021CIBA CORNING 348 SYSTEMCHLSubstantially EquivalentCiba Corning Diagnostics Corp.accessdata.fda.gov
February 3, 1994K935830CIBA CORNING 248 PH/BLOOD GAS ANALYZERCHLSubstantially EquivalentCiba Corning Diagnostics Corp.accessdata.fda.gov
January 3, 1994K934907860 MEASURMENT SYSTEMCHLSubstantially EquivalentCiba Corning Diagnostics Corp.accessdata.fda.gov
May 28, 1987K871028CIBA CORNING MODEL 664/FAST 4 SYSTEMJGSSubstantially EquivalentCiba Corning Diagnostics Corp.accessdata.fda.gov

Compare with other makers

Updated March 27, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.