FDA 510(k) Applications Submitted by R & D SYSTEMS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130962 |
04/08/2013 |
R&D 5D RETIC HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K961673 |
05/01/1996 |
R&D RETIC-PG HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K972170 |
06/09/1997 |
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION |
R & D SYSTEMS, INC. |
| K003874 |
12/15/2000 |
CBC-4K HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K010409 |
02/12/2001 |
CBC-SF |
R & D SYSTEMS, INC. |
| K010461 |
02/16/2001 |
ADVIA RETIC PLUS |
R & D SYSTEMS, INC. |
| K010470 |
02/20/2001 |
R & D 4K RETIC |
R & D SYSTEMS, INC. |
| K982231 |
06/25/1998 |
STATUSFLOW |
R & D SYSTEMS, INC. |
| K993321 |
10/04/1999 |
R&D HGB/GLC WHOLE BLOOD CONTROL |
R & D SYSTEMS, INC. |
| K003208 |
10/13/2000 |
R & D 3K RETIC |
R & D SYSTEMS, INC. |
| K003534 |
11/16/2000 |
PENTRA 5D |
R & D SYSTEMS, INC. |
| K984099 |
11/17/1998 |
QBC CENTRIFUGAL HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K964767 |
11/27/1996 |
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( |
R & D SYSTEMS, INC. |
| K003991 |
12/26/2000 |
CD-CAL PLUS CALIBRATOR |
R & D SYSTEMS, INC. |
| K970718 |
02/26/1997 |
QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) |
R & D SYSTEMS, INC. |
| K961610 |
04/25/1996 |
R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) |
R & D SYSTEMS, INC. |
| K100050 |
01/08/2010 |
R & D SYSTEMS XERET HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K091433 |
05/13/2009 |
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K101578 |
06/07/2010 |
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K072096 |
07/31/2007 |
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 |
R & D SYSTEMS, INC. |
| K072268 |
08/15/2007 |
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S |
R & D SYSTEMS, INC. |
| K072846 |
10/04/2007 |
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 |
R & D SYSTEMS, INC. |
| K073178 |
11/13/2007 |
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 |
R & D SYSTEMS, INC. |
| K020229 |
01/23/2002 |
R & D BODY FLUID CONTROL |
R & D SYSTEMS, INC. |
| K070334 |
02/05/2007 |
R&D SICKLE QC CONTROL |
R & D SYSTEMS, INC. |
| K061320 |
05/11/2006 |
R&D LH-NRBC HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K051339 |
05/23/2005 |
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K061511 |
06/01/2006 |
R&D CBC-3D + CRP HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K042094 |
08/03/2004 |
R&D CBC-XE HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K013898 |
11/23/2001 |
R&D RET-LINE KIT |
R & D SYSTEMS, INC. |
| K034048 |
12/30/2003 |
R&D GLU-LINE HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K160606 |
03/02/2016 |
BC-5D Hematology Control |
R & D SYSTEMS, INC. |
| K970331 |
01/28/1997 |
CBC-4K HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K991876 |
06/02/1999 |
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE |
R & D SYSTEMS, INC. |
| K972172 |
06/09/1997 |
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION |
R & D SYSTEMS, INC. |
| K983032 |
08/31/1998 |
CBC-5D HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
| K955925 |
12/22/1995 |
CBC-CAL PLUS HEMATOLOGY CALIBRATOR |
R & D SYSTEMS, INC. |
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