COLOR DIAGNOSTICS, LLC

FDA Device Registration & Listing · South San Francisco, CA, US · Registration 3011845225

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011845225
FEI Number
3011845225
Entity Name
COLOR DIAGNOSTICS, LLC
City/State/Country
South San Francisco, CA, US
Establishment Address
365 Oyster Point Blvd, Suite 300-3A, South San Francisco, CA 94080, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Color Diagnostics, LLC (Owner Number: 10086172)
Owner / Operator Contact Address
365 Oyster Point Blvd, Suite 300-3A, South San Francisco, CA 94080, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K152556
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2022-10-19
OYJ Dna Specimen Collection, Saliva Clinical Chemistry Class 2 862.1675 2025-02-24

Official Correspondent

FDA Team

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Color Diagnostics, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011845225. Last updated year: 2026. Please use registration number 3011845225 when referencing this establishment in official correspondence.
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