Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Earlitec Diagnostics with 4 510(k) clearances and 4 AI-enabled devices. The most recent is a 510(k) clearance dated Mar 5, 2026: EarliPoint Assessment.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 5, 2026 | EarliPoint AssessmentK253442 · QPF | 510(k) clearances |
| Mar 5, 2026 | EarliPoint AssessmentK253442 · Neurology | AI-enabled devices |
| Mar 26, 2025 | EarliPoint SystemK243891 · QPF | 510(k) clearances |
| Mar 26, 2025 | EarliPoint SystemK243891 · Neurology | AI-enabled devices |
| Jun 29, 2023 | EarliPointK230337 · QPF | 510(k) clearances |
| Jun 29, 2023 | EarliPointK230337 · Neurology | AI-enabled devices |
| Jun 8, 2022 | EarliPoint SystemK213882 · QPF | 510(k) clearances |
| Jun 8, 2022 | EarliPoint SystemK213882 · Neurology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
