Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009099956

FEI Number

3009099956

Entity Name

PLEXISION, INC

City/State/Country

Pittsburgh, PA, US

Establishment Address

4424 PENN AVENUE, SUITE 202, Pittsburgh, PA 15224, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

PLEXISION, INC (Owner Number: 10060336)

Owner / Operator Contact Address

4424 PENN AVENUE, SUITE 202, Pittsburgh, PA 15224, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

H130004

All Registered Proprietary Names

PLEXIMMUNE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHK	Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation	Unknown	Class N	N/A	2019-04-26

Official Correspondent

ASHOK REDDY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PLEXISION, INC

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 3009099956. Last updated year: 2026. Please use registration number 3009099956 when referencing this establishment in official correspondence.