FDA Registration
Active
🇯🇵 Japan
Power Express
Reg #: 3015969360
·
FEI: 3015969360
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Kikuyo Factory
- Registration Number
- 3015969360
- FEI Number
- 3015969360
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1552-1 Aza Kazaawa, Oaza Magate, Kikuyo-machi, Kikuchi-gun
- City
- Kumamoto
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K140496
Owner / Operator
- Firm Name
- IDS CO, LTD
- Operator Number
- 10049986
- Address
- 8-14-30 Nagaminehigashi, Higashi-ku
- City
- Kumamoto-shi
- State
- JP-43
- Postal Code
- 861-8038
- Country
- JP
- Correspondent
- Jay H Kessler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2015-09-25 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2015-09-25 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2015-09-25 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2015-09-25 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2015-09-25 |
Proprietary Names
Power Express
Establishment Types
Manufacture Medical Device