FDA Registration
Active
🇯🇵 Japan
PHC Corporation
Reg #: 3029973107
·
FEI: 3029973107
·
Expires 2026
Products
8
Proprietary Names
11
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- PHC Corporation
- Registration Number
- 3029973107
- FEI Number
- 3029973107
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1460-6 Aza-Mitodai, Mito
- City
- Tako-machi Katori-gun Chiba
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K072288
Owner / Operator
- Firm Name
- PHC Corporation
- Operator Number
- 9052268
- Address
- 2131-1 MINAMIGATA
- City
- TOON
- State
- Ehime
- Postal Code
- 791-0395
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fibrin Split Products | GHH | Class 2 | Hematology | No | 2023-11-16 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2023-11-16 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2023-11-16 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2023-11-16 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2024-03-28 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2023-11-16 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2023-11-16 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2023-11-15 |
Proprietary Names
PATHFAST D-Dimer
PATHFAST Sample Diluent 1
PATHFAST Myo-II
PATHFAST CK-MB-II
PATHFAST hs-cTnI-II
PATHFAST hsCRP
PATHFAST Sample Diluent 2
PATHFAST cTnI-II
PATHFAST NTproBNP
PATHFAST
PATHFAST TIP
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility