Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1529254

FEI Number

1000305932

Entity Name

LOUISVILLE APL DIAGNOSTICS, INC.

City/State/Country

Texas City, TX, US

Establishment Address

702 9TH ST N STE A, Texas City, TX 77590, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LOUISVILLE APL DIAGNOSTICS, INC. (Owner Number: 9008974)

Owner / Operator Contact Address

702 9TH ST N STE A, --, Texas City, TX 77590, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K933588

PMA Number

N/A

All Registered Proprietary Names

LAPL aB2GPI HRP ELISA Kit LAPL aB2GPI HRP ELISA Kit APhL ELISA® IgM HRP Kit APhL ELISA® IgG and IgM HRP Kit APhL ELISA® IgG HRP Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2013-12-31
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2013-12-31
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2014-08-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LOUISVILLE APL DIAGNOSTICS, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K091556	Instrumentation Laboratory CO	HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS	2010-05-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2008	Louisville Apl Diagnostics Inc	2	APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1529254. Last updated year: 2026. Please use registration number 1529254 when referencing this establishment in official correspondence.