Data / Medical devices / United States / Color Diagnostics, LLC
Color Diagnostics, LLC: FDA-registered device maker in South San Francisco, CA, United States, 4 510(k) clearances
Color Diagnostics, LLC is registered with the FDA (registration 3011845225) in South San Francisco, CA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 2, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011845225
- Address
- 365 Oyster Point Blvd Suite 300-3A, South San Francisco, CA, United States, 94080
- Owner or operator
- Color Diagnostics, LLC (10086172)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- October 19, 2022
- Registered through
- 2026
- Brand names listed
- Color Cancer Cardio DBS, Color Cancer FIT IO, Color Cancer HPV, Color Cancer PSA DBS, Color Cancer PSA Tasso, Color Cervical Cancer Screening, Color NGS Domestic Client Saliva Kit, Color NGS International Client Saliva Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Occult Blood Analyzer | OOX | 2 | Specification developer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Specification developer | accessdata.fda.gov |
| Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | SEP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dna Specimen Collection, Saliva | OYJ | 2 | Specification developer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2026 | K260184 | Onclarity Self-Collection Kit | SEP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| August 12, 2022 | K221131 | Tasso+ | FMK | Substantially Equivalent | Tasso, Inc. | accessdata.fda.gov |
| January 2, 2020 | K191147 | OC-Auto SENSOR io iFOB Test | OOX | Substantially Equivalent | Eiken Chemical Co., Ltd. | accessdata.fda.gov |
| May 26, 2016 | K152556 | Oragene Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Automated Occult Blood Analyzer
- All makers of Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
- All makers of Dna Specimen Collection, Saliva
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Updated April 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.