FDA Registration
Active
🇯🇵 Japan
DENKA CO., LTD.
Reg #: 3003871639
·
FEI: 3003871639
·
Expires 2026
Products
18
Proprietary Names
27
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- DENKA CO., LTD.
- Registration Number
- 3003871639
- FEI Number
- 3003871639
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1359-1, KAGAMIDA, KIGOSHI
- City
- GOSEN-SHI Niigata
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K081231
Owner / Operator
- Firm Name
- DENKA CO., LTD.
- Operator Number
- 9053049
- Address
- 1359-1, KAGAMIDA, KIGOSHI
- City
- GOSEN-SHI
- State
- Niigata
- Postal Code
- 959-1695
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2008-10-22 |
| Enzyme Immunoassay, Phenobarbital | DLZ | Class 2 | Clinical Toxicology | No | 2008-10-22 |
| Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test | PYP | Class 1 | Clinical Chemistry | No | 2018-02-28 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 2012-03-11 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2018-12-25 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2008-05-07 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-11-06 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2012-03-08 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2012-03-08 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2012-03-11 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2008-05-07 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2012-03-11 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2008-09-19 |
| Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | LGR | Class 2 | Clinical Toxicology | No | 2008-09-19 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2009-08-24 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2006-03-30 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2018-05-30 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2018-05-30 |
Proprietary Names
ARCHTECT iPhenobarbital
s LDL-EX "SEIKEN"
small dense LDL Seiken
VCP ASO/RF PVs & CALI KIT 28
BMG Latex X1 & Calibrator Set F
CRP (II) Calibrators
Immuno Q-Sera II
Urine Protein Control
Alinity i Insulin Controls
ARCHITECT Insulin Calibrators
ARCHITECT Insulin Controls
FERRITIN, ANTIGEN, ANTISERUM, CONTROLCalibrator, secondary
VCP RHEUMATOID FACTOR CALIBRATOR KIT 16
CRP-Latex (II) X2 SEIKEN Assay Kit
Rheumatoid Factor Calibrator
Rheumatoid Factor Test Kit
VCP LIPID CALIBRATOR KIT 19
ARCHITECT iPhenytoin Immunoassay
ARCHITECT iPhenytoin Calibrators (A-F)
ARCHITECT iValproic Acid Assay
ARCHITECT (R) INSULIN REAGENTS, Alinity i Insulin Reagent Kit
Alinity i Insulin Calibrators
Alinity c Rheumatoid Factor Calibrator Kit
Lipid Control S-I , Lipid Control S-II
small dense LDL-Control Set
Lipid Calibrator S
small dense LDL-Calibrator
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)