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Data / Medical devices / Japan / Beckman Coulter K. K.

Beckman Coulter K. K.: FDA-registered device maker in Sunto-Gun Shizuoka, Japan, 4 510(k) clearances

Beckman Coulter K. K. is registered with the FDA (registration 3008244372) in Sunto-Gun Shizuoka, Japan. It lists 32 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 16, 2016. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Beckman Coulter K. K.
FDA registration number
3008244372
Address
454-32 Higashino, Nagaizumi-Cho, Sunto-Gun Shizuoka, Japan, 411-0931
Owner or operator
BECKMAN COULTER, INC. (2050012)
Roles
Specification developer
First device listed
August 13, 2009
Registered through
2026
Brand names listed
B86443 DxC 700 AU, B86444 DxC 700 AU with ISE, B86445 DxC 700 AU for Direct Track Sampling, B86446 DxC 700 AU for Direct Track Sampling with ISE, Beckman Coulter Chemistry Analyzer AU480, Beckman Coulter Chemistry Analyzer AU5800, Beckman Coulter Chemistry Analyzer AU680, PK7400 and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid Phosphatase, Naphthyl PhosphateCKB2Specification developeraccessdata.fda.gov
Acid, Uric, Uricase (U.V.)CDO1Specification developeraccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Specification developeraccessdata.fda.gov
Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, ControlDEF1Specification developeraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Specification developeraccessdata.fda.gov
Atp And Creatine Kinase (Enzymatic), CreatineJLB1Specification developeraccessdata.fda.gov
Breast Milk, Rhodamine, Antigen, Antiserum, ControlDGI1Specification developeraccessdata.fda.gov
Bromcresol Green Dye-Binding, AlbuminCIX2Specification developeraccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Specification developeraccessdata.fda.gov
Complement C3, Antigen, Antiserum, ControlCZW2Specification developeraccessdata.fda.gov
Cresolphthalein Complexone, CalciumCIC2Specification developeraccessdata.fda.gov
Diazo Colorimetry, BilirubinCIG2Specification developeraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Specification developeraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Specification developeraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Specification developeraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Specification developeraccessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding CapacityJMO1Specification developeraccessdata.fda.gov
Gas Chromatography, AmphetamineDOD2Specification developeraccessdata.fda.gov
Hexokinase, GlucoseCFR2Specification developeraccessdata.fda.gov
Mercuric Thiocyanate, Colorimetry, ChlorideCHJ2Specification developeraccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or IsoenzymesCGS2Specification developeraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Specification developeraccessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesCJE2Specification developeraccessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic PhosphorusCEO1Specification developeraccessdata.fda.gov
Photometric Method, Iron (Non-Heme)JIY1Specification developeraccessdata.fda.gov
Photometric Method, MagnesiumJGJ1Specification developeraccessdata.fda.gov
Radioimmunoassay, Immunoglobulins (G, A, M)CFQ2Specification developeraccessdata.fda.gov
System, Test, Automated Blood Grouping And AntibodyKSZ2Specification developeraccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Specification developeraccessdata.fda.gov
System, Test, Rheumatoid FactorDHR2Specification developeraccessdata.fda.gov
Turbidimetric Method, LipoproteinsJHN1Specification developeraccessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea NitrogenCDQ2Specification developeraccessdata.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
December 16, 2016K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerJGSSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
December 23, 2011K112412AU5800(R) CHEMISTRY ANALYZERCEMSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
June 9, 1998K981743OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZERCKBSubstantially EquivalentOlympus America, Inc.accessdata.fda.gov
July 5, 1996K961274OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZERJJESubstantially EquivalentOlympus America, Inc.accessdata.fda.gov

Compare with other makers

Updated December 16, 2016. 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.