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Data / Medical devices / Japan / PHC Corporation

PHC Corporation: FDA-registered device maker in Chiyoda-ku Tokyo, Japan, 16 510(k) clearances and 2 PMA approvals

PHC Corporation is registered with the FDA (registration 3014353045) in Chiyoda-ku Tokyo, Japan. It lists 15 device types. The FDA files 16 510(k) clearances and 2 PMA approvals under its listings, the newest dated March 20, 2024. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch PHC Corporation
FDA registration number
3014353045
Address
15F DAI-ICHI LIFE HIBIYA FIRST 1-13-2 Yurakucho, Chiyoda-ku Tokyo, Japan, 100-8403
Owner or operator
PHC Corporation (9052268)
Roles
Exporter to the US
First device listed
September 24, 2003
Registered through
2027
Brand names listed
CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR NEXT ONE Blood Glucose Monitoring System, CONTOUR NEXT Test Strip, Contour Next EZ Blood Glucose Meter, Contour Next Link 2.4, Contour Next, Contour Next Link, Contour Next One, MCO-170MP, MCO-50M and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Assisted Reproduction, ExemptPUB2Exporter to the USaccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Exporter to the USaccessdata.fda.gov
Automated Insulin Dosing , Threshold SuspendOZO3Exporter to the USaccessdata.fda.gov
Automated Insulin Dosing Device System, Single Hormonal ControlOZP3Exporter to the USaccessdata.fda.gov
Calibrator, SecondaryJIT2Exporter to the USaccessdata.fda.gov
Fibrin Split ProductsGHH2Exporter to the USaccessdata.fda.gov
Fluorometric Method, Cpk Or IsoenzymesJHX2Exporter to the USaccessdata.fda.gov
Glucose Dehydrogenase, GlucoseLFR2Exporter to the USaccessdata.fda.gov
Immunoassay Method, Troponin SubunitMMI2Exporter to the USaccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Exporter to the USaccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Exporter to the USaccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Exporter to the USaccessdata.fda.gov
System, Test, Breath Nitric OxideMXA2Exporter to the USaccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Exporter to the USaccessdata.fda.gov
Test, Natriuretic PeptideNBC2Exporter to the USaccessdata.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 20, 2024K231974PATHFAST®hs-cTnI-IIMMISubstantially EquivalentPhc Corporationaccessdata.fda.gov
November 8, 2019K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring SystemNBWSubstantially EquivalentAscensia Diabetes Careaccessdata.fda.gov
November 22, 2017K170983NIOX VEROMXASubstantially EquivalentCircassia ABaccessdata.fda.gov
January 12, 2017K162336Contour Next EZ Blood Glucose Monitoring SystemNBWSubstantially EquivalentAscensia Diabetes Care U.S., Inc.accessdata.fda.gov
November 17, 2016K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemNBWSubstantially EquivalentAscensia Diabetes Careaccessdata.fda.gov
February 26, 2015K150233NIOX VERO Airway Inflammation MonitorMXASubstantially EquivalentAerocrine ABaccessdata.fda.gov
November 6, 2014K133898NIOX VERO AIRWAY INFLAMMATION MONITORMXASubstantially EquivalentAerocrine ABaccessdata.fda.gov
June 23, 2014K130265CONTOUR NEXT EZ BLOOD GLUCOSE METERNBWSubstantially EquivalentBayer Healthcare, LLCaccessdata.fda.gov
July 26, 2012K121190CONTOUR NEXT BLOOD GLUCOSE METERLFRSubstantially EquivalentBayer Healthcare, LLCaccessdata.fda.gov
March 6, 2012K111268CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEMLFRSubstantially EquivalentBayer Healthcareaccessdata.fda.gov
May 16, 2011K100130PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2MMISubstantially EquivalentMitsubishi Chemical Medience COaccessdata.fda.gov
August 17, 2009K081360PATHFAST CK-MB-II, PATHFAST MYO-IIJHXSubstantially EquivalentMitsubishi Kagaku Iatronaccessdata.fda.gov
May 6, 2009K072288PATHFAST D-DIMERGHHSubstantially EquivalentMitsubishi Kagaku Iatronaccessdata.fda.gov
March 9, 2009K083412PATHFAST HSCRPDCNSubstantially EquivalentMitsubishi Kagaku Iatronaccessdata.fda.gov
February 5, 2008K072189PATHFAST NTPROBNP AND D-DIMER TESTSNBCSubstantially EquivalentMitsubishi Kagaku Iatronaccessdata.fda.gov
September 11, 2006K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080NBWSubstantially EquivalentBayer Healthcareaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
September 28, 2016P160017MiniMed 670G SystemOZP126September 29, 2026accessdata.fda.gov
August 10, 2016P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO100July 21, 2026accessdata.fda.gov

Compare with other makers

Updated September 29, 2026. 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.