FDA Registration
Active
🇯🇵 Japan
PHC Corporation
Reg #: 3014353045
·
FEI: 3014353045
·
Expires 2026
Products
15
Proprietary Names
19
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- PHC Corporation
- Registration Number
- 3014353045
- FEI Number
- 3014353045
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 15F DAI-ICHI LIFE HIBIYA FIRST, 1-13-2 Yurakucho
- City
- Chiyoda-ku Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K072189
- PMA Number
- P160017
Owner / Operator
- Firm Name
- PHC Corporation
- Operator Number
- 9052268
- Address
- 2131-1 MINAMIGATA
- City
- TOON
- State
- Ehime
- Postal Code
- 791-0395
- Country
- JP
US Agent
- Business Name
- PHC Corporation Of North America
- Contact Name
- Steven Hubbard
- Address
- 1300 MICHAEL DR , STE A
- City
- Wood Dale
- State
- IL
- ZIP
- 60191
- Country
- US
- [email protected]
- Phone
- 551 4829284
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | 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 |
| Automated Insulin Dosing Device System, Single Hormonal Control | OZP | Class 3 | Unknown | No | 2017-12-19 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2012-03-16 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2012-03-16 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2012-03-16 |
| Accessory, Assisted Reproduction, Exempt | PUB | Class 2 | Obstetrics/Gynecology | No | 2017-09-24 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2024-03-28 |
| Automated Insulin Dosing , Threshold Suspend | OZO | Class 3 | Unknown | No | 2016-08-11 |
| System, Test, Breath Nitric Oxide | MXA | Class 2 | Clinical Toxicology | No | 2014-11-14 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2023-11-16 |
| Fibrin Split Products | GHH | Class 2 | Hematology | No | 2023-11-16 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2023-11-15 |
Proprietary Names
PATHFAST NTproBNP
PATHFAST Sample Diluent 1
PATHFAST Myo-II
PATHFAST CK-MB-II
Contour Next Link 2.4
CONTOUR NEXT Test Strip
MCO-50M
MCO-170MP
PATHFAST hs-cTnI-II
CONTOUR NEXT ONE Blood Glucose Monitoring System
Contour Next, Contour Next Link, Contour Next One
PATHFAST hsCRP
Contour Next EZ Blood Glucose Meter
PATHFAST D-Dimer
CONTOUR BLOOD GLUCOSE TEST STRIPS
PATHFAST Sample Diluent 2
PATHFAST cTnI-II
PATHFAST
PATHFAST TIP
Establishment Types
Export Device to the United States But Perform No Other Operation on Device