R D Systems Inc

FDA Filings

This page includes the latest FDA filings for R D Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2182501
FEI Number2182501
NameR & D SYSTEMS, INC.
Owner & OperatorR & D SYSTEMS, INC.
Contact Address614 MCKINLEY PL., N.E. --
Minneapolis MN 55413 US
Official Correspondent
  • Alicia M Felthauser
  • x-612-6564501-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address614 MCKINLEY PL., N.E.
MINNEAPOLIS, MN 55413 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
R & D SYSTEMS, INC.
Human Total 25-OH Vitamin D IVD ELISA Kit2018-12-14
R & D SYSTEMS, INC.
CBC-PIX2017-09-05
R & D SYSTEMS, INC.
CBC-DX2017-09-05
R & D SYSTEMS, INC.
CBC-DH2017-09-05
R & D SYSTEMS, INC.
BC-5D Hematology Controls2016-11-23
R & D SYSTEMS, INC.
BC-5D Hematology Control2016-09-01
R & D SYSTEMS, INC.
R&D 5D RETIC HEMATOLOGY CONTROL2013-07-24
R & D SYSTEMS, INC.
Body Fluid-I Control2011-05-02
R & D SYSTEMS, INC.
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL2011-04-28
R & D SYSTEMS, INC.
HGB Extended2010-12-01
R & D SYSTEMS, INC.
CBC-82010-12-01
R & D SYSTEMS, INC.
CBC-72010-12-01
R & D SYSTEMS, INC.
CBC-7 for Hemocue2010-12-01
R & D SYSTEMS, INC.
XERet Hematology Control2010-02-01
R & D SYSTEMS, INC.
R & D SYSTEMS XERET HEMATOLOGY CONTROL2010-01-29
R & D SYSTEMS, INC.
Retic-I2009-11-02
R & D SYSTEMS, INC.
Retic Hematology Control2009-11-02
R & D SYSTEMS, INC.
NEK-CAL2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus for Mindray2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus for Abacus2009-11-01
R & D SYSTEMS, INC.
NEK-CAL2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus for Mindray2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus for Abacus2009-11-01
R & D SYSTEMS, INC.
NEK-CAL2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus for Mindray2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus for Abacus2009-11-01
R & D SYSTEMS, INC.
NEK-CAL2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus for Mindray2009-11-01
R & D SYSTEMS, INC.
CBC-CAL Plus for Abacus2009-11-01
R & D SYSTEMS, INC.
R&D Retic-I Plus2009-11-01
R & D SYSTEMS, INC.
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL2009-10-28
R & D SYSTEMS, INC.
QBC Hematology Control2008-01-02
R & D SYSTEMS, INC.
StatusFlow Lo2008-01-02
R & D SYSTEMS, INC.
Status Flow2008-01-02
R & D SYSTEMS, INC.
PLT-LINE Linearity Kit2008-01-02
R & D SYSTEMS, INC.
CBC-LINE for HemoCue Linearity Kit2008-01-02
R & D SYSTEMS, INC.
CBC-LINE Ultra Low Plus RBC Hematology Linearity Kit2008-01-02
R & D SYSTEMS, INC.
CBC-LINE Ultra Low Linearity Kit2008-01-02
R & D SYSTEMS, INC.
CBC-LINE Low Range Linearity Kit2008-01-02
R & D SYSTEMS, INC.
CBC-LINE Linearity Kit2008-01-02
R & D SYSTEMS, INC.
CBC-X2008-01-02
R & D SYSTEMS, INC.
CBC-Tech2008-01-02
R & D SYSTEMS, INC.
Tech -Cal2008-01-02
R & D SYSTEMS, INC.
Platelet-Trol II2008-01-02
R & D SYSTEMS, INC.
CBC-3D2008-01-02
R & D SYSTEMS, INC.
CBC-3D for Mindray2008-01-02
R & D SYSTEMS, INC.
R&D Platelet-Trol Extended2008-01-02
R & D SYSTEMS, INC.
3K Retic Hematology Control2008-01-02
R & D SYSTEMS, INC.
Status FlowPro2008-01-02
R & D SYSTEMS, INC.
Leuko-Reduced Plt Control2008-01-02
R & D SYSTEMS, INC.
Leuko-Reduced RBC Control2008-01-02
R & D SYSTEMS, INC.
Glu/Hgb Whole Blood Control2007-12-31
R & D SYSTEMS, INC.
Glu/Hgb Whole Blood Control2007-12-31
R & D SYSTEMS, INC.
SEDRite Plus2007-12-31
R & D SYSTEMS, INC.
SEDRite III2007-12-31
R & D SYSTEMS, INC.
Diesse ESR Control2007-12-31
R & D SYSTEMS, INC.
CBC-5D Hematology Control2007-12-31
R & D SYSTEMS, INC.
Quantikine IVD Human Soluble Transf2007-12-31
R & D SYSTEMS, INC.
Quantikine IVD Erythropoitin ELISA2007-12-31
R & D SYSTEMS, INC.
Quantikine Erythropoitin Control2007-12-31
R & D SYSTEMS, INC.
HCT Extended Control2007-12-31
R & D SYSTEMS, INC.
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT0042007-12-27
R & D SYSTEMS, INC.
CD-CAL2007-12-05
R & D SYSTEMS, INC.
CD-CAL2007-12-05
R & D SYSTEMS, INC.
CD-CAL2007-12-05
R & D SYSTEMS, INC.
CD-CAL2007-12-05
R & D SYSTEMS, INC.
CBC-SYS Hematology Control2007-12-03
R & D SYSTEMS, INC.
R&D ADVIA Retic plus2007-11-30
R & D SYSTEMS, INC.
CELL-DYN Drift Control2007-11-30
R & D SYSTEMS, INC.
CBC-4K2007-11-30
R & D SYSTEMS, INC.
CBC-3K2007-11-30
R & D SYSTEMS, INC.
CSF Automated Control2007-11-27
R & D SYSTEMS, INC.
HC WBC Hematology Control2007-11-27
R & D SYSTEMS, INC.
CBC-5D Plus Retics Hematology Contr2007-11-27
R & D SYSTEMS, INC.
Sickle QC Hematology Control2007-11-27
R & D SYSTEMS, INC.
CBC-3D+CRP Hematology Control2007-11-27
R & D SYSTEMS, INC.
LH-nRBC Hematology Control2007-11-27
R & D SYSTEMS, INC.
CBC-4K Plus Retics2007-11-27
R & D SYSTEMS, INC.
CBC-XE Hematology Control2007-11-27
R & D SYSTEMS, INC.
GLU-LINE Linearity Kit2007-11-27
R & D SYSTEMS, INC.
Body Fluid Control2007-11-27
R & D SYSTEMS, INC.
RET-LINE Linearity Kit2007-11-27
R & D SYSTEMS, INC.
RET-LINE C Linearity Kit2007-11-27
R & D SYSTEMS, INC.
RET-LINE B Linearity Kit2007-11-27
R & D SYSTEMS, INC.
4K Retic Hematology Control2007-11-27
R & D SYSTEMS, INC.
Plasma Hemoglobin Hematology Contro2007-11-27
R & D SYSTEMS, INC.
CSF AUTOMATED CONTROL, MODELS CSF001, CSF0032007-11-26
R & D SYSTEMS, INC.
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S2007-11-20
R & D SYSTEMS, INC.
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR042007-08-20
R & D SYSTEMS, INC.
R&D SICKLE QC CONTROL2007-03-29
R & D SYSTEMS, INC.
R&D CBC-3D + CRP HEMATOLOGY CONTROL2006-07-10
R & D SYSTEMS, INC.
R&D LH-NRBC HEMATOLOGY CONTROL2006-06-02
R & D SYSTEMS, INC.
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL2005-07-12
R & D Systems, Inc
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2004-09-17
R & D SYSTEMS, INC.
R&D CBC-XE HEMATOLOGY CONTROL2004-09-01
R & D SYSTEMS, INC.
R&D GLU-LINE HEMATOLOGY CONTROL2004-03-10
R & D SYSTEMS, INC.
R & D BODY FLUID CONTROL2002-02-06
R & D SYSTEMS, INC.
R&D RET-LINE KIT2002-01-22
R & D SYSTEMS, INC.
R & D 4K RETIC2001-05-11
R & D SYSTEMS, INC.
ADVIA RETIC PLUS2001-04-03
R & D SYSTEMS, INC.
CBC-SF2001-03-16
R & D SYSTEMS, INC.
CD-CAL PLUS CALIBRATOR2001-01-16
R & D SYSTEMS, INC.
CBC-4K HEMATOLOGY CONTROL2001-01-12
R & D Systems, Inc
Automated Differential Cell Counter2000-12-13
R & D Systems, Inc
Automated Differential Cell Counter2000-12-13
R & D SYSTEMS, INC.
PENTRA 5D2000-12-01
R & D SYSTEMS, INC.
R & D 3K RETIC2000-11-07
R & D SYSTEMS, INC.
R&D HGB/GLC WHOLE BLOOD CONTROL1999-11-12
R & D Systems, Inc
Automated Differential Cell Counter1999-06-21
R & D SYSTEMS, INC.
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE1999-06-17
R & D SYSTEMS, INC.
CBC-5D HEMATOLOGY CONTROL1999-02-17
R & D SYSTEMS, INC.
QBC CENTRIFUGAL HEMATOLOGY CONTROL1998-12-10
R & D SYSTEMS, INC.
STATUSFLOW1998-07-20
R & D SYSTEMS, INC.
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION1997-07-24
R & D SYSTEMS, INC.
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION1997-07-24
R & D SYSTEMS, INC.
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(1997-05-29
R & D SYSTEMS, INC.
QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)1997-05-27
R & D SYSTEMS, INC.
CBC-4K HEMATOLOGY CONTROL1997-04-16

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Related Finance Registrations
NCAGE Code04VX1R D SYSTEMS INC
NCAGE Code1RS71R. D. SYSTEMS, INC.
CAGE Code04VX1R D SYSTEMS INC
CAGE Code1RS71R. D. SYSTEMS, INC.
S.A.M. Registration1RS71 [131840365]R. D. SYSTEMS, INC.
SEC0000351141R&D SYSTEMS INC
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020061327955Hong Kong,Hong Kong -> Long Beach, CaliforniaAUTO HEMATOLOGY ANALYZER5 PKG
2020060440512Hong Kong,Hong Kong -> Long Beach, CaliforniaAUTO HEMATOLOGY ANALYZER5 PKG
2020031934213Hong Kong,Hong Kong -> Long Beach, CaliforniaREAGENT KIT118 CTN
2020021845254Bremerhaven,Federal Republic of Germany -> New York, New YorkPROJECT WCL DOBBY 1 LMMUCOAT-COATING LINE B S06, COMPLETE INCL ACCESSORIES, SERIAL NO. 261 PCS
201909178876Kobe,Japan -> Los Angeles, CaliforniaSURFACE-ACTIVE, WASHING, PREPARATIONS3 CTN
2019091020238Kobe,Japan -> Los Angeles, CaliforniaSURFACE-ACTIVE, WASHING, PREPARATIONS3 CTN
2019083041438Kobe,Japan -> Los Angeles, CaliforniaSURFACE-ACTIVE, WASHING, PREPARATIONS3 CTN
2019072941782Yantian,China (Mainland) -> Los Angeles, CaliforniaLYA-1/2/3 LYSE;LYE-1 LYSE; LYC-1/2 LYSE DIL-A /DIL-E/DIL-C DILUENT CLE-P CLEANSER 36 CARTON S36 CTN
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