FDA Registration
Active
🇺🇸 United States
K-ASSAY(R) Cystatin C Control
Reg #: 2084025
·
FEI: 2084025
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- KAMIYA BIOMEDICAL COMPANY LLC
- Registration Number
- 2084025
- FEI Number
- 2084025
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 12779 Gateway Dr S
- City
- Tukwila
- State
- WA
- ZIP
- 98168
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093137
Owner / Operator
- Firm Name
- KAMIYA BIOMEDICAL COMPANY LLC
- Operator Number
- 9001370
- Address
- 12779 GATEWAY DRIVE S
- City
- Tukwila
- State
- WA
- Postal Code
- 98168
- Country
- US
- Correspondent
- COLIN GETTY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Cystatin C | NDY | Class 2 | Clinical Chemistry | No | 2010-10-12 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2010-10-12 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2010-10-12 |
Proprietary Names
K-ASSAY(R) Cystatin C Control
K-ASSAY(R) Cystatin C
K-ASSAY(R) Cystatin C Calibrator
Establishment Types
Manufacture Medical Device