Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007135538

FEI Number

3007135538

Entity Name

KALEO, INC.

City/State/Country

Glen Allen, VA, US

Establishment Address

10900 Nuckols Rd Ste 200, Glen Allen, VA 23060, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Kaleo, Inc. (Owner Number: 10085920)

Owner / Operator Contact Address

10900 Nuckols Road, Suite 200, Glen Allen, VA 23060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Naloxone HCl Injection, USP Auto-Injector, 10 mg AUVI-Q

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSC	Injector, Pen	General Hospital	Class 2	880.5860	2022-09-09

Official Correspondent

Emily Rafferty

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kaleo, Inc.

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 3007135538. Last updated year: 2026. Please use registration number 3007135538 when referencing this establishment in official correspondence.