# Earlitec Diagnostics, Inc.

- Location (FDA's records): Atlanta, GA
- FDA decisions: 4 (2022–2026): 4 510(k) clearances
- Names in FDA's records: Earlitec Diagnostics, Inc. (2); Earlitec Diagnostics (2)
- Product codes: QPF (4)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cognoa, Inc.: 1 (https://510kreport.com/company/cognoa)

## Its most-cited devices
- K213882: EarliPoint System (2022), cited by 1
- K243891: EarliPoint System (2025), cited by 1
- K230337: EarliPoint (2023), cited by 1

## Recent decisions
- K253442: EarliPoint Assessment (Mar 5, 2026)
- K243891: EarliPoint System (Mar 26, 2025)
- K230337: EarliPoint (Jun 29, 2023)
- K213882: EarliPoint System (Jun 8, 2022)

Source page: https://510kreport.com/company/earlitec-diagnostics