Earlitec Diagnostics

Earlitec Diagnostics — FDA 510(k) Submissions

Earlitec Diagnostics has submitted 2 FDA 510(k) premarket notifications since 2025, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Pediatric Autism Spectrum Disorder Diagnosis Aid . Use the specialty filter in the sidebar to narrow results.