EARLITEC DIAGNOSTICS

FDA Device Registration & Listing · Plymouth, MN, US · Registration 3027553518

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027553518
FEI Number
3027553518
Entity Name
EARLITEC DIAGNOSTICS
City/State/Country
Plymouth, MN, US
Establishment Address
13895 Industrial Park Blvd Ste 140, Plymouth, MN 55441, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
EarliTec Diagnostics (Owner Number: 10088360)
Owner / Operator Contact Address
13895 Industrial Park Blvd, Suite 140, Plymouth, MN 55441, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K253442
PMA Number
N/A

All Registered Proprietary Names

EarliPoint EarliPoint EarliPoint

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QPF Pediatric Autism Spectrum Disorder Diagnosis Aid Neurology Class 2 882.1491 2023-07-06
QPF Pediatric Autism Spectrum Disorder Diagnosis Aid Neurology Class 2 882.1491 2025-12-03
QPF Pediatric Autism Spectrum Disorder Diagnosis Aid Neurology Class 2 882.1491 2026-03-16

Official Correspondent

Ryan Bormann

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EarliTec Diagnostics
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027553518. Last updated year: 2026. Please use registration number 3027553518 when referencing this establishment in official correspondence.
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