Louisville Apl Diagnostics Inc

Texas City, TX, US

LOUISVILLE APL DIAGNOSTICS, INC. appears in FDA device records in Texas City, TX. FDA records list 3 510(k) clearances between 1994-10-13 and 2002-08-27, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 6 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 6
Registered establishments: 1

510(k) clearance history

FDA records hold 3 510(k) clearances for Louisville Apl Diagnostics Inc between 1994 and 2002. The busiest year on record is 1994, with 1. The most recent is 2002, with 1.

Clearances by year, as a table

510(k) clearance decisions for Louisville Apl Diagnostics Inc, by decision year
Year	Clearances
1994	1
1999	1
2002	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K021398	APL IGA ELISA KIT	MID	Substantially Equivalent	2002-08-27
K984102	ACL/APS FACS KIT	MID	Substantially Equivalent	1999-03-18
K933588	APHLELISA KIT	MID	Substantially Equivalent	1994-10-13

Registered establishments

FDA registered establishments for Louisville Apl Diagnostics Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1529254	1000305932	LOUISVILLE APL DIAGNOSTICS, INC.	702 9TH ST N STE A, Texas City, TX 77590 US	2026	MID MSV

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Initiated	Status
Z-0034-2008	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).	Product mislabeled; outer container labeled with incorrect lot number.	2006-07-18	Terminated
Z-1177-2007	APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. --(current address now in Seabrook, TX 77586).	Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.	2005-10-06	Terminated
Z-1176-2007	APhL HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc.-- (current address now in Seabrook, TX 77586).	Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.	2005-10-06	Terminated
Z-1175-2007	APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).	Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.	2005-10-06	Terminated
Z-1104-2007	american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgG ELISA Kit, Product #649G; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.	Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.	2004-08-10	Terminated
Z-1103-2007	american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.	Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.	2004-08-10	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain