FDA Registration
Active
🇺🇸 United States
Color NGS Domestic Client Saliva Kit
Reg #: 3011845225
·
FEI: 3011845225
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COLOR DIAGNOSTICS, LLC
- Registration Number
- 3011845225
- FEI Number
- 3011845225
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 863 Mitten Road, Suite 100F
- City
- Burlingame
- State
- CA
- ZIP
- 94010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152556
Owner / Operator
- Firm Name
- Color Diagnostics, LLC
- Operator Number
- 10086172
- Address
- 863 Mitten Road, Suite 100F
- City
- Burlingame
- State
- CA
- Postal Code
- 94010
- Country
- US
- Correspondent
- FDA Team
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dna Specimen Collection, Saliva | OYJ | Class 2 | Clinical Chemistry | No | 2025-02-24 |
Proprietary Names
Color NGS Domestic Client Saliva Kit
Color NGS International Client Saliva Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility