Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035380687

FEI Number

3035380687

Entity Name

TARGETED GENOMICS, LLC

City/State/Country

Irvine, CA, US

Establishment Address

5 Mason, Irvine, CA 92618, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Targeted Genomics, LLC (Owner Number: 10092509)

Owner / Operator Contact Address

5 Mason, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241456

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTA	Genetic Variant Detection And Health Risk Assessment System	Immunology	Class 2	866.5950	2025-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Targeted Genomics, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3015489159	ALOM Technologies Corporation	Indianapolis, IN, US
3003436513	ASURAGEN, INC.	AUSTIN, TX, US
3004597845	ALOM TECHNOLOGIES CORPORATION	FREMONT, CA, US
3038181305	FORTUNA HELIX	Seoul, KR
3018077536	SUPERA FULFILLMENT LLC	Houston, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035380687. Last updated year: 2026. Please use registration number 3035380687 when referencing this establishment in official correspondence.