FDA Registration
Active
🇯🇵 Japan
BD Vacutainer Rapid Serum Tube (RST
Reg #: 3006850222
·
FEI: 3006850222
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SEKISUI MEDICAL CO., LTD. Tokuyama Plant
- Registration Number
- 3006850222
- FEI Number
- 3006850222
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4560,Kaisei-cho
- City
- Shunan-City Yamaguchi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K101502
Owner / Operator
- Firm Name
- SEKISUI MEDICAL CO., LTD.
- Operator Number
- 10023817
- Address
- 1-3, Nihonbashi 2-chome, Chuo-ku
- City
- Tokoyo
- State
- Tokyo
- Postal Code
- 103-0027
- Country
- JP
US Agent
- Business Name
- Sekisui Diagnostics, LLC
- Contact Name
- Jason Bilobram
- Address
- One Wall Street
- City
- Burlington
- State
- MA
- ZIP
- 01803
- Country
- US
- [email protected]
- Phone
- 781 6527848
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2010-08-16 |
Proprietary Names
BD Vacutainer Rapid Serum Tube (RST
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)