Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016690356

FEI Number

3016690356

Entity Name

ARC-ONE SOLUTIONS, LLC

City/State/Country

Orlando, FL, US

Establishment Address

8669 Commodity Cir, Orlando, FL 32819, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ARC-ONE Solutions (Owner Number: 10068067)

Owner / Operator Contact Address

8669 Commodity Circle, Orlando, FL 32819, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK200512

PMA Number

N/A

All Registered Proprietary Names

Regulated Software Application (RSA), Version 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2021-01-28

Official Correspondent

Adrienne Hammond

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARC-ONE Solutions

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 3016690356. Last updated year: 2026. Please use registration number 3016690356 when referencing this establishment in official correspondence.