Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011015335

FEI Number

3011015335

Entity Name

CLEVELAND DIAGNOSTICS, INC.

City/State/Country

Cleveland, OH, US

Establishment Address

3615 Superior Ave Ste 4406a, Cleveland, OH 44114, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device,Reprocess Single-Use Device

Owner / Operator

Cleveland Diagnostics, Inc. (Owner Number: 10095401)

Owner / Operator Contact Address

3615 Superior Avenue, Suite 4406A, Cleveland, OH 44114, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P200048

All Registered Proprietary Names

IsoPSA Assay

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QRF	Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2026-03-09

Official Correspondent

Mark Muyinda

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cleveland 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 3011015335. Last updated year: 2026. Please use registration number 3011015335 when referencing this establishment in official correspondence.