ROWNY SYSTEMS, INC.

FDA Device Registration & Listing · Gaithersburg, MD, US · Registration 3009768528

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
3009768528
FEI Number
3009768528
Entity Name
ROWNY SYSTEMS, INC.
City/State/Country
Gaithersburg, MD, US
Establishment Address
166 Gold Kettle Dr, Gaithersburg, MD 20878, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Rowny Systems, Inc. (Owner Number: 10041559)
Owner / Operator Contact Address
6508 81st St., Cabin John, MD 20818, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK110045
PMA Number
N/A

All Registered Proprietary Names

Antigen Plus

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 2012-08-06

Official Correspondent

Alan Martinson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rowny Systems, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009768528. Last updated year: 2026. Please use registration number 3009768528 when referencing this establishment in official correspondence.
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