FDA Registration
Active
🇺🇸 United States
KAWASUMI LABORATORIES AMERICA, INC.
Reg #: 1055927
·
FEI: 1000113359
·
Expires 2026
Products
8
Proprietary Names
0
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- KAWASUMI LABORATORIES AMERICA, INC.
- Registration Number
- 1055927
- FEI Number
- 1000113359
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 10002 PRINCESS PALM AVENUE, SUITE 324
- City
- Tampa
- State
- FL
- ZIP
- 33619
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190485
Owner / Operator
- Firm Name
- SB-KAWASUMI LABORATORIES, INC.
- Operator Number
- 8031539
- Address
- 3-25-4 Tonomachi, Kawasaki-ku
- City
- Kawasaki-shi
- State
- Kanagawa
- Postal Code
- 210-8602
- Country
- JP
- Correspondent
- Kenichi - Inamura
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2019-07-09 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2026-04-20 |
| Non-Coring (Huber) Needle | PTI | Class 2 | General Hospital | No | 2026-04-20 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-06-09 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2008-03-03 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2018-10-11 |
| Set, Transfer (Blood/Plasma) | KSB | Class 2 | Hematology | No | 2018-10-11 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2008-01-09 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198