Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009297077

FEI Number

3009297077

Entity Name

Diatron MI Plc

City/State/Country

Budapest, HU

Establishment Address

Tablas str. 39, Budapest H-1097, HU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Diatron MI Plc (Owner Number: 10040448)

Owner / Operator Contact Address

Tablas u. 39, Budapest, HU-BU H-1097, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111534

PMA Number

N/A

All Registered Proprietary Names

Pictus 700 Clinical Chemistry Analyzer P500, Diatron Pictus 500 APK300, Autopak 300 Clinical Chemistry Autoanalyzer P780 Clinical Chemistry Analyzer Abacus 5 Hematology Analyzer Abacus 5 Autoloader Trigger Solution 1 KleeYa Trigger Solutions Pack Trigger Solution 2 Diatro Diff-5P Diatro Lyse-DIFF Diatro Lyse-5P Diatro Cleaner Additive for wash solution Cuvette Cleaner Solutions Solution1 Hypochlorite Cleaning Solution Solution2 Rinsing Solution Cuvette Cleaner Solution3 Additive for Wash Solution 5x TBS Wash Buffer Diatro Hypoclean Cleaning Solution Cleaning kit Diatro Hypoclean CC Diatro Dil 5P Diatro Dil DIFF Abacus 3CP Hematology Analyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2015-08-08
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-04-16
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2023-01-26
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2014-04-22
JCB	Detergent	Pathology	Class 1	864.4010	2014-04-22
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2014-04-22
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-08-07

Official Correspondent

Andras Vamos

US Agent Details

Frank Matuszak Business: Diatron US Inc. Email: Frank.Matuszak@Diatron.com Phone: (833) 2287931

Related Public Records

Same Entity

Diatron MI Plc

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019	Radiometer America Inc	1	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

Registration Number	Establishment Name	Location
3007500635	Immunodiagnostic Systems SA	Liege, BE
3008853996	Ningbo MedicalSystem Biotechnology Co., Ltd.	Ningbo Zhejiang, CN
1319809	ORTHO-CLINICAL DIAGNOSTICS, INC.	ROCHESTER, NY, US
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009297077. Last updated year: 2026. Please use registration number 3009297077 when referencing this establishment in official correspondence.