Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003630693

FEI Number

3003630693

Entity Name

CELLAVISION AB

City/State/Country

LUND Skane, SE

Establishment Address

Mobilvagen 12, LUND Skane SE-22362, SE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

CellaVision AB (Owner Number: 9043433)

Owner / Operator Contact Address

Mobilvagen 12, --, LUND, SE-NOTA SE-22362, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092868

PMA Number

N/A

All Registered Proprietary Names

CellaVision Body Fluid Application for DM1200, DM9600 and DI-60 CellaVision Body Fluid Application Cellavision Body Fluid Application Non-Expiring license, DM96 CellaVision Server Software CellaVision DM96 and DM1200 with Advanced RBC Application DI-60 with Advanced RBC Application CellaVision DM9600 with Advanced RBC Application HemaPrep Automated Digital Cell Morphology Analyzer DI-60 CellaVision DM9600 CellaVision DM1200

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2011-11-03
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2010-07-07
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2010-07-07
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2017-06-19
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2017-10-27
GKJ	Spinner, Slide, Automated	Hematology	Class 1	864.5850	2018-08-30
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2010-07-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2010-07-07

Official Correspondent

Charlotte Oom

US Agent Details

Scott Dunbar Business: - Email: scott.dunbar@cellavision.com Phone: (919) 8064420

Related Public Records

Same Entity

CellaVision AB

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

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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3009834076	KITRON AB	Jonkoping, SE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003630693. Last updated year: 2026. Please use registration number 3003630693 when referencing this establishment in official correspondence.