Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2248933

FEI Number

3000206772

Entity Name

RICHMOND DIAGNOSTICS, INC.

City/State/Country

North Brunswick, NJ, US

Establishment Address

525 Milltown Road, Suite 403-404, North Brunswick, NJ 08902, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RICHMOND DIAGNOSTICS, INC. (Owner Number: 9028307)

Owner / Operator Contact Address

525 Milltown Road, Suite 403-404, North Brunswick, NJ 08902, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hematachek

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GLK	Control, Hematocrit	Hematology	Class 2	864.8625	2006-01-30

Official Correspondent

DAVID SHICK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RICHMOND DIAGNOSTICS, 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 2248933. Last updated year: 2026. Please use registration number 2248933 when referencing this establishment in official correspondence.