FDA applicant

Earlitec Diagnostics, Inc.

Atlanta, GA4 decisions2022–20260 recalls

FDA records 4 decisions for Earlitec Diagnostics, Inc. (Atlanta, GA) from 2022 to 2026: 4 510(k) clearances. All are in product code QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid). Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Earlitec Diagnostics”.

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

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

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

FDA decisions per year

1in 2025

2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Earlitec Diagnostics, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Earlitec Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Earlitec Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?