Data / Medical devices / United States / Louisville Apl Diagnostics, Inc.
Louisville Apl Diagnostics, Inc.: FDA-registered device maker in Texas City, TX, United States, 5 510(k) clearances
Louisville Apl Diagnostics, Inc. is registered with the FDA (registration 1529254) in Texas City, TX, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 27, 2002. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1529254
- FEI number
- 1000305932
- Address
- 702 9TH ST N Ste A, Texas City, TX, United States, 77590
- Owner or operator
- LOUISVILLE APL DIAGNOSTICS, INC. (9008974)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 11, 2008
- Registered through
- 2026
- Brand names listed
- APL ELISA Kit, APhL ELISA® IgG HRP Kit, APhL ELISA® IgG and IgM HRP Kit, APhL ELISA® IgM HRP Kit, LAPL aB2GPI HRP ELISA Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Test, Anticardiolipin Immunological | MID | 2 | Manufacturer | accessdata.fda.gov |
| System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | MSV | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2002 | K021398 | APL IGA ELISA KIT | MID | Substantially Equivalent | Louisville Apl Diagnostics, Inc. | accessdata.fda.gov |
| September 28, 2001 | K013080 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT | MSV | Substantially Equivalent | Corgenix, Inc. | accessdata.fda.gov |
| September 28, 2001 | K013079 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT | MSV | Substantially Equivalent | Corgenix, Inc. | accessdata.fda.gov |
| September 28, 2001 | K013077 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT | MSV | Substantially Equivalent | Corgenix, Inc. | accessdata.fda.gov |
| October 13, 1994 | K933588 | APHLELISA KIT | MID | Substantially Equivalent | Louisville Apl Diagnostics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 18, 2006 | 39412 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
| October 6, 2005 | 38396 | Not yet classified | Terminated | 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 | Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits. | accessdata.fda.gov |
| August 10, 2004 | 38313 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- All makers of System, Test, Anticardiolipin Immunological
Updated October 4, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.