Data / Medical devices / Japan / PHC Corporation
PHC Corporation: FDA-registered device maker in Tako-machi Katori-gun Chiba, Japan, 6 510(k) clearances
PHC Corporation is registered with the FDA (registration 3029973107) in Tako-machi Katori-gun Chiba, Japan. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 20, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3029973107
- Address
- 1460-6 Aza-Mitodai, Mito, Tako-machi Katori-gun Chiba, Japan, 2892247
- Owner or operator
- PHC Corporation (9052268)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 15, 2023
- Registered through
- 2027
- Brand names listed
- PATHFAST, PATHFAST CK-MB-II, PATHFAST D-Dimer, PATHFAST Myo-II, PATHFAST NTproBNP, PATHFAST Sample Diluent 1, PATHFAST Sample Diluent 2, PATHFAST TIP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Fibrin Split Products | GHH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Immunoassay Method, Troponin Subunit | MMI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Myoglobin, Antigen, Antiserum, Control | DDR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Test, C-Reactive Protein | DCN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Test, Natriuretic Peptide | NBC | 2 | Complaint file establishment, Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 20, 2024 | K231974 | PATHFAST®hs-cTnI-II | MMI | Substantially Equivalent | Phc Corporation | accessdata.fda.gov |
| May 16, 2011 | K100130 | PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 | MMI | Substantially Equivalent | Mitsubishi Chemical Medience CO | accessdata.fda.gov |
| August 17, 2009 | K081360 | PATHFAST CK-MB-II, PATHFAST MYO-II | JHX | Substantially Equivalent | Mitsubishi Kagaku Iatron | accessdata.fda.gov |
| May 6, 2009 | K072288 | PATHFAST D-DIMER | GHH | Substantially Equivalent | Mitsubishi Kagaku Iatron | accessdata.fda.gov |
| March 9, 2009 | K083412 | PATHFAST HSCRP | DCN | Substantially Equivalent | Mitsubishi Kagaku Iatron | accessdata.fda.gov |
| February 5, 2008 | K072189 | PATHFAST NTPROBNP AND D-DIMER TESTS | NBC | Substantially Equivalent | Mitsubishi Kagaku Iatron | accessdata.fda.gov |
Compare with other makers
- All makers of Calibrator, Secondary
- All makers of Immunoassay Method, Troponin Subunit
- All makers of Test, Natriuretic Peptide
- All makers of Fluorometric Method, Cpk Or Isoenzymes
- All makers of Myoglobin, Antigen, Antiserum, Control
- All makers of Fibrin Split Products
Updated March 20, 2024. 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.