FDA.reportPublic FDA data

EARLITEC DIAGNOSTICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30275535183027553518EARLITEC DIAGNOSTICS1N2026-01-0113895 Industrial Park Blvd Ste 140 Plymouth MN US 55441

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860009993709EarliPoint - The EarliPoint System is an eye tracking device used as a tool to aid clinicians in the diagnosis and assessment of ASD patients.833-504-9937info@earlitecdx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3187881565016757K253442EarliPoint AssessmentQPF2026-03-05
3187881899082937K243891EarliPoint SystemQPF2025-03-26
3187881798468369K230337EarliPointQPF2023-06-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QPF32026-03-05

PMN#

GUDID#