R & D SYSTEMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2182501	2182501	R & D SYSTEMS, INC.	1	N	2026-01-01	614 Mckinley Pl Ne MINNEAPOLIS MN US 55413

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
35705	1228690809	K993321	R&D HGB/GLC WHOLE BLOOD CONTROL	GGM	1999-11-12
35705	1591109251	K991876	SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE	JPK	1999-06-17
35705	1014063122	K984099	QBC CENTRIFUGAL HEMATOLOGY CONTROL	JPK	1998-12-10
35705	1382776275	K983032	CBC-5D HEMATOLOGY CONTROL	JPK	1999-02-17
35705	1796887440	K982231	STATUSFLOW	GKZ	1998-07-20
35705	1417334241	K970718	QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)	JNM	1997-05-27
35705	1835236832	K961610	R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)	GKZ	1996-07-01
35705	1396440371	K955925	CBC-CAL PLUS HEMATOLOGY CALIBRATOR	KRX	1996-02-29
35705	1057597188	K943336	RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE	JPK	1994-12-12
35705	1754962196	K942822	CBC-LINE HEMATOLOGY LINEARITY CONTROL	JPK	1994-10-07
35705	1608918504	K936016	QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)	GGT	1994-07-19
35705	1972140341	K931756	QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS	GGT	1994-04-21
35705	1732591139	K913879	CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE	JPK	1991-11-27
35705	1882870126	K890749	CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE	JPK	1989-02-27
35705	1500596539	K881161	TECH-CAL(TM)/MULTIPLE	KSA	1988-05-02
35705	1872100811	K854353	PLATELET-TROL II	JPK	1985-11-26
35705	1496058714	K843962	CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE	JPK	1984-11-01
35705	1555146102	K840302	PLT - 4 PLATELET	JPK	1984-03-12
35705	1695179508	K802265	CBC PLT-4	JPK	1980-11-12
35705	1677825535	K160606	BC-5D Hematology Control	JPK	2016-09-01
35705	1585309724	K123364	25OH VITAMIN D TOTAL ELISA TEST	MRG	2013-07-15
35705	1652059949	K101578	R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL	JPK	2011-04-28
35705	1199823989	K100050	R & D SYSTEMS XERET HEMATOLOGY CONTROL	JPK	2010-01-29
35705	1913215341	K091433	R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL	JPK	2009-10-28
35705	1172809658	K073178	HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004	JPK	2007-12-27
35705	1274386967	K072846	CSF AUTOMATED CONTROL, MODELS CSF001, CSF003	JPK	2007-11-26
35705	1043728897	K072268	HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S	JPK	2007-11-20
35705	1340844943	K072096	CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04	JPK	2007-08-20
35705	1221726248	K070334	R&D SICKLE QC CONTROL	GGM	2007-03-29
35705	1454008932	K061511	R&D CBC-3D + CRP HEMATOLOGY CONTROL	JPK	2006-07-10
35705	1843430773	K061320	R&D LH-NRBC HEMATOLOGY CONTROL	JPK	2006-06-02
35705	1213995928	K051339	R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL	JPK	2005-07-12
35705	1990894215	K050721	ABX ERYTROL	JPK	2005-06-01
35705	1913642214	K042094	R&D CBC-XE HEMATOLOGY CONTROL	JPK	2004-09-01
35705	1108849734	K034048	R&D GLU-LINE HEMATOLOGY CONTROL	JJX	2004-03-10
35705	1028007030	K020229	R & D BODY FLUID CONTROL	JPK	2002-02-06
35705	1373958494	K013898	R&D RET-LINE KIT	JPK	2002-01-22
35705	1618174832	K010470	R & D 4K RETIC	JPK	2001-05-11
35705	2033280811	K010461	ADVIA RETIC PLUS	JPK	2001-04-03
35705	1985403022	K010409	CBC-SF	JPK	2001-03-16
35705	1956905875	K003991	CD-CAL PLUS CALIBRATOR	KRX	2001-01-16
35705	1814099466	K003874	CBC-4K HEMATOLOGY CONTROL	JPK	2001-01-12
35705	2016253249	K003534	PENTRA 5D	JPK	2000-12-01
35705	1660408147	K003208	R & D 3K RETIC	JPK	2000-11-07
35705	1768938266	K002511	FETALTROL	JPK	2000-09-11
35705	1630038894	BK990005
35705	1483895431	BK040063
35705	1510618586	BK000036
35705	1750536353	BK000035
35705	1025296576
35705	1606209642
35705	1943619224

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JPK	34	2016-09-01
GGM	2	2007-03-29
KRX	2	2001-01-16
GKZ	2	1998-07-20
GGT	2	1994-07-19
MRG	1	2013-07-15
JJX	1	2004-03-10
JNM	1	1997-05-27
KSA	1	1988-05-02

PMN#

BC-5D Hematology Control
2016-09-01
R & D SYSTEMS, INC.
R&D 5D RETIC HEMATOLOGY CONTROL
2013-07-24
R & D SYSTEMS, INC.
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
2011-04-28
R & D SYSTEMS, INC.
R & D SYSTEMS XERET HEMATOLOGY CONTROL
2010-01-29
R & D SYSTEMS, INC.
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
2009-10-28
R & D SYSTEMS, INC.
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
2007-12-27
R & D SYSTEMS, INC.
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
2007-11-26
R & D SYSTEMS, INC.
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
2007-11-20
R & D SYSTEMS, INC.
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
2007-08-20
R & D SYSTEMS, INC.
R&D SICKLE QC CONTROL
2007-03-29
R & D SYSTEMS, INC.
R&D CBC-3D + CRP HEMATOLOGY CONTROL
2006-07-10
R & D SYSTEMS, INC.
R&D LH-NRBC HEMATOLOGY CONTROL
2006-06-02
R & D SYSTEMS, INC.
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
2005-07-12
R & D SYSTEMS, INC.
R&D CBC-XE HEMATOLOGY CONTROL
2004-09-01
R & D SYSTEMS, INC.
R&D GLU-LINE HEMATOLOGY CONTROL
2004-03-10
R & D SYSTEMS, INC.
R & D BODY FLUID CONTROL
2002-02-06
R & D SYSTEMS, INC.
R&D RET-LINE KIT
2002-01-22
R & D SYSTEMS, INC.
R & D 4K RETIC
2001-05-11
R & D SYSTEMS, INC.
ADVIA RETIC PLUS
2001-04-03
R & D SYSTEMS, INC.
CBC-SF
2001-03-16
R & D SYSTEMS, INC.
CD-CAL PLUS CALIBRATOR
2001-01-16
R & D SYSTEMS, INC.
CBC-4K HEMATOLOGY CONTROL
2001-01-12
R & D SYSTEMS, INC.
PENTRA 5D
2000-12-01
R & D SYSTEMS, INC.
R & D 3K RETIC
2000-11-07
R & D SYSTEMS, INC.
R&D HGB/GLC WHOLE BLOOD CONTROL
1999-11-12
R & D SYSTEMS, INC.
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
1999-06-17
R & D SYSTEMS, INC.
CBC-5D HEMATOLOGY CONTROL
1999-02-17
R & D SYSTEMS, INC.
QBC CENTRIFUGAL HEMATOLOGY CONTROL
1998-12-10
R & D SYSTEMS, INC.
STATUSFLOW
1998-07-20
R & D SYSTEMS, INC.
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
1997-07-24
R & D SYSTEMS, INC.
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
1997-07-24
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 CONTROL
1997-04-16
R & D SYSTEMS, INC.
R&D RETIC-PG HEMATOLOGY CONTROL
1996-07-15
R & D SYSTEMS, INC.
R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
1996-07-01
R & D SYSTEMS, INC.
CBC-CAL PLUS HEMATOLOGY CALIBRATOR
1996-02-29
R & D SYSTEMS, INC.
Qbc Centrifugal Hematology Control
1995-10-06
R & D SYSTEMS, INC.
Retic Control-m Hematology Control/multiple
1994-12-12
R & D SYSTEMS, INC.
RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
1994-12-12
R & D SYSTEMS, INC.

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