FDA applicant

Louisville Apl Diagnostics, Inc.

Doraville, GA3 decisions1994–20026 recalls

FDA records 3 decisions for Louisville Apl Diagnostics, Inc. (Doraville, GA) from 1994 to 2002: 3 510(k) clearances. All are in product code MID (System, Test, Anticardiolipin Immunological). 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Louisville Apl Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Louisville Apl Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Louisville Apl Diagnostics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Louisville”

FDA records each applicant name separately; these may or may not be the same firm.

Louisville Laboratories, Inc. 12

Louisville Apl Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Louisville”