Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008425728

FEI Number

3008425728

Entity Name

DIATRON US INC

City/State/Country

Medley, FL, US

Establishment Address

12601 NW 115th Avenue, Suite A 113, Medley, FL 33178, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Diatron U.S. Inc (Owner Number: 10037043)

Owner / Operator Contact Address

12601 NW 115th Avenue Suite A 113, Medley, FL 33178, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Diatro Dil DIFF Diatro Dil 5P Abacus 5 Abacus 3CP P500, Diatron Pictus 500 APK300, Autopak 300 Clinical Chemistry Autoanalyzer Pictus 700 Clinical Chemistry Analyzer P780 Clinical Chemistry Analyzer Diatro Lyse 5P Diatro Diff 5P Diatro Lyse DIFF 5x TBS Wash Buffer Solution 3 Additive for Wash Solution Solution1 Hypochlorite Cleaning Solution Diatro Hypoclean Cleaning Solution Cleaning kit Diatro Hypoclean CC Additive for wash solution Diatro Cleaner Cuvette Cleaner Solutions Solution 2 Rinsing Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2014-08-29
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-04-03
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-08-07
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2015-08-08
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2014-08-29
JCB	Detergent	Pathology	Class 1	864.4010	2014-08-29

Official Correspondent

Frank Matuszak

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Diatron U.S. Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008425728. Last updated year: 2026. Please use registration number 3008425728 when referencing this establishment in official correspondence.