Medical Device Manufacturer · US , Atlanta , GA

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

2 submissions · 2 cleared · Since 2022

Total

Cleared

Denied

Earlitec Diagnostics, Inc. has 2 FDA 510(k) cleared medical devices. Based in Atlanta, US.

Last cleared in 2023. Active since 2022. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Earlitec Diagnostics, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Libramedical, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.

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

2 devices

1-2 of 2

Cleared CT Jun 08, 2022

EarliPoint System

K213882 · QPF

Neurology · 177d

Regulatory Intelligence

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

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

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