FDA Registration
Active
🇺🇸 United States
COLOR DIAGNOSTICS, LLC
Reg #: 3011845225
·
FEI: 3011845225
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- COLOR DIAGNOSTICS, LLC
- Registration Number
- 3011845225
- FEI Number
- 3011845225
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 365 Oyster Point Blvd, Suite 300-3A
- City
- South San Francisco
- State
- CA
- ZIP
- 94080
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152556
Owner / Operator
- Firm Name
- Color Diagnostics, LLC
- Operator Number
- 10086172
- Address
- 365 Oyster Point Blvd, Suite 300-3A
- City
- South San Francisco
- State
- CA
- Postal Code
- 94080
- Country
- US
- Correspondent
- FDA Team
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2022-10-19 |
| Dna Specimen Collection, Saliva | OYJ | Class 2 | Clinical Chemistry | No | 2025-02-24 |
| Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | SEP | Class 2 | Microbiology | No | 2026-05-08 |
| Automated Occult Blood Analyzer | OOX | Class 2 | Hematology | No | 2025-02-24 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2025-02-24 |
Proprietary Names
Color Cancer PSA DBS
Color Cancer Cardio DBS
Color Cancer HPV
Color NGS International Client Saliva Kit
Color NGS Domestic Client Saliva Kit
Color Cervical Cancer Screening
Color Cancer FIT IO
Color Cancer PSA Tasso
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device