Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2182501

FEI Number

2182501

Entity Name

R & D SYSTEMS, INC.

City/State/Country

MINNEAPOLIS, MN, US

Establishment Address

614 Mckinley Pl Ne, MINNEAPOLIS, MN 55413, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

R & D SYSTEMS, INC. (Owner Number: 2182501)

Owner / Operator Contact Address

614 MCKINLEY PL., N.E., --, Minneapolis, MN 55413, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K843962

PMA Number

N/A

All Registered Proprietary Names

Quantikine IVD Erythropoitin ELISA Retic-I Retic Hematology Control StatusFlow Lo Glu/Hgb Whole Blood Control CBC-XE Hematology Control Bio Rad Liquicheck Hematology Control (X) CBC-X Hematology Control XERet Hematology Control Body Fluid-I Control 4K Retic Hematology Control CELL-DYN Drift Control CBC-3K CBC-LINE for HemoCue Linearity Kit PLT-LINE Linearity Kit CBC-LINE Linearity Kit CBC-LINE Ultra Low Linearity Kit CBC-LINE Low Range Linearity Kit CBC-LINE Ultra Low Plus RBC Hematology Linearity Kit CBC-5D Hematology Control CBC-PIX Hematology Control R&D ADVIA Retic plus Sickle QC Hematology Control CD-CAL CBC-SYS Hematology Control Status FlowPro Body Fluid Control 3K Retic Hematology Control Leuko-Reduced Plt Control R&D CBC-DH Hematology Control R&D CBC-XR Hematology Control R&D CBC-ST Hematology Control R&D CBC-XN Hematology Control CBC-CAL Plus for Abacus CBC-CAL Plus CBC-CAL Plus for Mindray NEK-CAL Tech -Cal BC-5D Hematology Controls R&D Retic-I for DxH-800 Status Flow CBC-3D+CRP Hematology Control Quantikine Erythropoitin Control R&D Platelet-Trol Extended CBC-Tech CBC-3D for Mindray CBC-3D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGT	Assay, Erythropoietin	Hematology	Class 2	864.7250	2007-12-31
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2009-11-02
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-01-02
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2007-12-31
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-31
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-11-27
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2010-02-01
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2011-05-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-11-27
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-11-30
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2008-01-02
JCN	Control, Cell Counter, Normal And Abnormal	Hematology	Class 2	864.8625	2017-09-05
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-11-30
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2007-11-27
KSA	Calibrator For Red-Cell And White-Cell Counting	Hematology	Class 2	864.8185	2007-12-05
KRY	Calibrator For Platelet Counting	Hematology	Class 2	864.8175	2007-12-05
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2007-12-05
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2007-12-05
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-12-03
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-01-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-11-27
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2008-01-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2009-11-01
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-01-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2023-06-27
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2009-11-01
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2009-11-01
KRY	Calibrator For Platelet Counting	Hematology	Class 2	864.8175	2009-11-01
KSA	Calibrator For Red-Cell And White-Cell Counting	Hematology	Class 2	864.8185	2009-11-01
KSA	Calibrator For Red-Cell And White-Cell Counting	Hematology	Class 2	864.8185	2008-01-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2016-11-23
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2009-11-01
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-01-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2008-01-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-11-27
GGT	Assay, Erythropoietin	Hematology	Class 2	864.7250	2007-12-31
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2008-01-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2008-01-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2008-01-02

Official Correspondent

Mary Anne Williams

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

R & D SYSTEMS, 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
K781077	Dade, Baxter Travenol Diagnostics, Inc.	CONTROL, HEMATOLOGY, CH-60	1978-07-27
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12

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 2182501. Last updated year: 2026. Please use registration number 2182501 when referencing this establishment in official correspondence.