Medical Device Manufacturer · US , Mchenry , IL

R&D Systems, Inc.

79 submissions · 79 cleared · Since 1978
79
Total
79
Cleared
0
Denied

R&D Systems, Inc. — FDA 510(k) Submissions

R&D Systems, Inc. has submitted 79 FDA 510(k) premarket notifications since 1978, of which 79 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Mixture, Hematology Quality Control, Calibrator For Cell Indices, Control, Hemoglobin, Calibrator For Red-cell And White-cell Counting, Control, Cell Counter, Normal And Abnormal . Use the specialty filter in the sidebar to narrow results.

79 devices
1–25 of 79
BC-5D Hematology Control
K160606 · JPK Mixture, Hematology... · Hematology
Sep 2016 183d
R&D 5D RETIC HEMATOLOGY CONTROL
K130962 · JPK Mixture, Hematology... · Hematology
Jul 2013 107d
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
K101578 · JPK Mixture, Hematology... · Hematology
Apr 2011 325d
R & D SYSTEMS XERET HEMATOLOGY CONTROL
K100050 · JPK Mixture, Hematology... · Hematology
Jan 2010 21d
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
K091433 · JPK Mixture, Hematology... · Hematology
Oct 2009 168d
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
K073178 · JPK Mixture, Hematology... · Hematology
Dec 2007 44d
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
K072846 · JPK Mixture, Hematology... · Hematology
Nov 2007 53d
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
K072268 · JPK Mixture, Hematology... · Hematology
Nov 2007 97d
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
K072096 · JPK Mixture, Hematology... · Hematology
Aug 2007 20d
R&D SICKLE QC CONTROL
K070334 · GGM Control, Hemoglobin · Hematology
Mar 2007 52d
R&D CBC-3D + CRP HEMATOLOGY CONTROL
K061511 · JPK Mixture, Hematology... · Hematology
Jul 2006 39d
R&D LH-NRBC HEMATOLOGY CONTROL
K061320 · JPK Mixture, Hematology... · Hematology
Jun 2006 22d
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
K051339 · JPK Mixture, Hematology... · Hematology
Jul 2005 50d
R&D CBC-XE HEMATOLOGY CONTROL
K042094 · JPK Mixture, Hematology... · Hematology
Sep 2004 29d
R&D GLU-LINE HEMATOLOGY CONTROL
K034048 · JJX Single (specified)... · Chemistry
Mar 2004 71d
R & D BODY FLUID CONTROL
K020229 · JPK Mixture, Hematology... · Hematology
Feb 2002 14d
R&D RET-LINE KIT
K013898 · JPK Mixture, Hematology... · Hematology
Jan 2002 60d
R & D 4K RETIC
K010470 · JPK Mixture, Hematology... · Hematology
May 2001 80d
ADVIA RETIC PLUS
K010461 · JPK Mixture, Hematology... · Hematology
Apr 2001 46d
CBC-SF
K010409 · JPK Mixture, Hematology... · Hematology
Mar 2001 32d
CD-CAL PLUS CALIBRATOR
K003991 · KRX Calibrator For Cell Indices · Hematology
Jan 2001 21d
CBC-4K HEMATOLOGY CONTROL
K003874 · JPK Mixture, Hematology... · Hematology
Jan 2001 28d
PENTRA 5D
K003534 · JPK Mixture, Hematology... · Hematology
Dec 2000 15d
R & D 3K RETIC
K003208 · JPK Mixture, Hematology... · Hematology
Nov 2000 25d
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321 · GGM Control, Hemoglobin · Hematology
Nov 1999 39d

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