Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1043678

FEI Number

1043678

Entity Name

POREX CORPORATION

City/State/Country

FAIRBURN, GA, US

Establishment Address

500 Bohannon Rd, FAIRBURN, GA 30213, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Porex Corporation (Owner Number: 1043678)

Owner / Operator Contact Address

500 Bohannon Road, --, Fairburn, GA 30213, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K771985

PMA Number

N/A

All Registered Proprietary Names

POREX INLINE Reagent Filter POREX SQ-Easy PreFilter POREX INTAKE Reagent Filter FILTER SAMPLER Blood Serum Filter Standard Model Fisherband Serum Filters Dispense+ Serum Filter Fisherbrand Serum Filters Dispense Filter System Fisherbrand Serum Filters Standard Model Fisherbrand Serum Filters Instrument Specific Model FILTER SAMPLER, BLOOD SERUM FILTER Fisherband Serum Filters IB Model

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2009-09-15
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2016-10-12
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2016-08-23

Official Correspondent

Thelma Bess

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Porex Corporation

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1043678. Last updated year: 2026. Please use registration number 1043678 when referencing this establishment in official correspondence.