Medical Device Manufacturer · US , Atlanta , GA

Earlitec Diagnostics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2022

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Earlitec Diagnostics, Inc. Neurology ✕

2 devices

1-2 of 2

Linked clinical trials FDA-regulated device evidence

Regulatory consultant 510(k) submission support ecosystem

Libramedical, Inc.

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Clinical validation data available

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 16, 2026