Mixture, Hematology Quality Control

FDA product code JPK · 190 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.8625
Review panel: HE
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-04 – 2016-12-22

JPK 2016-12-22

XN CHECK

Applicant Streck

K number K160590

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JPK 2016-12-22

XN CHECK BF

Applicant Streck

K number K160588

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JPK 2016-12-22

XN-L CHECK

Applicant Streck

K number K160586

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JPK 2016-09-01

BC-5D Hematology Control

Applicant R&D Systems, Inc.

K number K160606

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JPK 2013-07-24

R&D 5D RETIC HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K130962

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JPK 2012-10-19

XN CHECK BF

Applicant Streck

K number K120744

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JPK 2012-10-19

XN CHECK

Applicant Streck

K number K120742

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JPK 2011-04-28

R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K101578

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JPK 2010-12-21

COULTER LIN-X LINEARITY CONTROL, MODEL A81196

Applicant Beckman Coulter, Inc.

K number K100790

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JPK 2010-11-18

COULTER 4C-EX 300 CELL CONTROL

Applicant Beckman Coulter, Inc.

K number K100607

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JPK 2010-08-02

LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV

Applicant Bio-Rad Laboratories

K number K091303

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JPK 2010-01-29

R & D SYSTEMS XERET HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K100050

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JPK 2009-10-28

R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K091433

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JPK 2009-03-27

UA-CELLULAR FOR IQ

Applicant Streck

K number K090201

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JPK 2009-02-03

COULTER BODY FLUID CONTROL

Applicant Beckman Coulter, Inc.

K number K082162

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JPK 2009-01-21

COULTER 6C CELL CONTROL, MODELS 628027 & A59925

Applicant Beckman Coulter, Inc.

K number K081822

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JPK 2009-01-16

COULTER LIN-X LINEARITY CONTROL

Applicant Beckman Coulter, Inc.

K number K081641

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JPK 2007-12-27

HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004

Applicant R&D Systems, Inc.

K number K073178

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JPK 2007-11-26

CSF AUTOMATED CONTROL, MODELS CSF001, CSF003

Applicant R&D Systems, Inc.

K number K072846

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JPK 2007-11-20

HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S

Applicant R&D Systems, Inc.

K number K072268

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JPK 2007-08-20

CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04

Applicant R&D Systems, Inc.

K number K072096

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JPK 2007-02-23

RETIC-CHEX LINEARITY FOR BC

Applicant Streck

K number K070199

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JPK 2006-12-14

E-CHECK (XE)

Applicant Streck

K number K063218

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JPK 2006-07-10

R&D CBC-3D + CRP HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K061511

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JPK 2006-06-02

R&D LH-NRBC HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K061320

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JPK 2006-05-17

COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503

Applicant Beckman Coulter, Inc.

K number K061064

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JPK 2006-03-28

COULTER 5C CELL CONTROL

Applicant Beckman Coulter, Inc.

K number K060464

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JPK 2006-01-13

CELL-CHEX AUTO

Applicant Streck

K number K053362

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JPK 2005-08-17

IQ BODY FLUIDS CONTROL

Applicant Streck

K number K051706

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JPK 2005-07-12

R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K051339

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JPK 2005-06-01

ABX ERYTROL

Applicant Horiba Abx

K number K050721

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JPK 2004-11-05

LIQUICHEK RETICULOCYTE CONTROL (A)

Applicant Bio-Rad

K number K042836

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JPK 2004-10-19

RETIC-CHEX FOR CELL-DYN

Applicant Streck Laboratories, Inc.

K number K042587

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JPK 2004-10-14

METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK

Applicant Bio-Rad Laboratories, Inc.

K number K042336

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JPK 2004-09-01

R&D CBC-XE HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K042094

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JPK 2004-06-28

LIQUICHEK HEMATOLOGY CONTROL (A)

Applicant Bio-Rad

K number K041457

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JPK 2003-01-14

CDS 3-PD HEMATOLOGY CONTROLS

Applicant Clinical Diagnostic Solutions, Inc.

K number K024173

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JPK 2002-09-24

ADVIA TESTPOINT CSF CONTROL

Applicant Bayer Diagnostics Corp.

K number K022968

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JPK 2002-06-25

MODIFICATION TO PARA 5X

Applicant Streck Laboratories, Inc.

K number K021922

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JPK 2002-02-06

R & D BODY FLUID CONTROL

Applicant R&D Systems, Inc.

K number K020229

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JPK 2002-01-22

R&D RET-LINE KIT

Applicant R&D Systems, Inc.

K number K013898

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JPK 2001-12-13

IMMUNO-TROL LOW CELLS

Applicant Beckman Coulter, Inc.

K number K013842

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JPK 2001-06-26

PARA 5X

Applicant Streck Laboratories, Inc.

K number K011410

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JPK 2001-05-11

R & D 4K RETIC

Applicant R&D Systems, Inc.

K number K010470

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JPK 2001-04-03

ADVIA RETIC PLUS

Applicant R&D Systems, Inc.

K number K010461

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JPK 2001-03-23

SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL

Applicant Quantimetrix Corp.

K number K010598

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JPK 2001-03-16

CBC-SF

Applicant R&D Systems, Inc.

K number K010409

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JPK 2001-02-07

5C-ES CELL CONTROL, MODELS 7547191, 7547192

Applicant Beckman Coulter, Inc.

K number K010066

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JPK 2001-02-07

4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190

Applicant Beckman Coulter, Inc.

K number K010064

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JPK 2001-01-12

CBC-4K HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K003874

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JPK 2000-12-01

PENTRA 5D

Applicant R&D Systems, Inc.

K number K003534

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JPK 2000-11-07

R & D 3K RETIC

Applicant R&D Systems, Inc.

K number K003208

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JPK 2000-09-11

FETALTROL

Applicant Trillium Diagnostics, LLC

K number K002511

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JPK 2000-03-27

RETIC CHEX LINEARITY

Applicant Streck Laboratories, Inc.

K number K000115

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JPK 1999-11-30

RETIC-QUINOX

Applicant Hematronix, Inc.

K number K993496

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JPK 1999-06-17

SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE

Applicant R&D Systems, Inc.

K number K991876

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JPK 1999-03-16

IMMUNO-TROL CONTROL CELLS

Applicant Coulter Corp.

K number K984216

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JPK 1999-02-17

CBC-5D HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K983032

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JPK 1998-12-10

QBC CENTRIFUGAL HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K984099

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JPK 1997-07-24

ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION

Applicant R&D Systems, Inc.

K number K972172

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JPK 1997-07-24

ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION

Applicant R&D Systems, Inc.

K number K972170

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JPK 1997-06-30

COULTER ACT TRON CELL CONTROL

Applicant Coulter Corp.

K number K971469

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JPK 1997-04-16

CBC-4K HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K970331

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JPK 1996-07-15

R&D RETIC-PG HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K961673

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JPK 1996-04-03

CALIBRATION VERIFICATION ASSESSMENT (CVA)

Applicant Streck Laboratories, Inc.

K number K960557

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JPK 1996-03-20

TRI-COUNT 20

Applicant Hematronix, Inc.

K number K960471

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JPK 1996-03-19

TRI-COURT 20-T

Applicant Hematronix, Inc.

K number K960005

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JPK 1996-02-08

COULTER LINEARITY CONTROL

Applicant Coulter Corp.

K number K955334

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JPK 1996-01-30

4C PLUS COULTER CELL CONTROL

Applicant Coulter Corp.

K number K955016

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JPK 1995-10-06

QBC CENTRIFUGAL HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K954137

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JPK 1995-09-20

AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II

Applicant Aalto Scientific, Ltd.

K number K952720

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JPK 1995-09-01

SF-CHECK

Applicant Streck Laboratories, Inc.

K number K952245

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JPK 1995-04-25

EZ-RANGE

Applicant Hematronix, Inc.

K number K941965

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JPK 1994-12-12

RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE

Applicant R&D Systems, Inc.

K number K943336

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JPK 1994-12-12

RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE

Applicant R&D Systems, Inc.

K number K943335

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JPK 1994-12-08

COULTER FLOW SET

Applicant Coulter Corp.

K number K944751

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JPK 1994-10-07

CBC-LINE HEMATOLOGY LINEARITY CONTROL

Applicant R&D Systems, Inc.

K number K942822

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JPK 1994-04-05

PARA 5 DIFF

Applicant Streck Laboratories, Inc.

K number K935196

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JPK 1994-03-22

CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE

Applicant R&D Systems, Inc.

K number K940089

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JPK 1994-03-09

SE-CHECK

Applicant Streck Laboratories, Inc.

K number K940181

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JPK 1994-01-27

CENTRIFIQ BLOOD CONTROL

Applicant Hematronix, Inc.

K number K935343

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JPK 1993-06-18

CHECKPOINT

Applicant Medical Specialties, Inc.

K number K931947

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JPK 1993-04-05

COULTER RETIC-C CELL CONTROL

Applicant Coulter Electronics, Inc.

K number K930119

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JPK 1992-11-16

QC-CHEX

Applicant Streck Laboratories, Inc.

K number K923971

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JPK 1991-12-18

GAS TRAK CONNECT BLOOD GAS CONTROL

Applicant Biochemical Sciences, Inc.

K number K914099

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JPK 1991-11-27

CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE

Applicant R&D Systems, Inc.

K number K913879

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JPK 1991-07-17

PX COULTER(R) CELL CONTROL

Applicant Coulter Electronics, Inc.

K number K912133

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JPK 1991-02-20

RETIC-CHEX

Applicant Streck Laboratories, Inc.

K number K905524

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JPK 1990-10-29

QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE

Applicant R&D Systems, Inc.

K number K904637

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JPK 1990-10-26

METER TRAX

Applicant Hematronix, Inc.

K number K904461

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JPK 1990-10-23

CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED

Applicant R&D Systems, Inc.

K number K904464

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JPK 1990-01-29

REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)

Applicant Helena Laboratories

K number K900017

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JPK 1989-07-25

HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL

Applicant Intercare Diagnostics, Inc.

K number K893895

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JPK 1989-05-16

PH BLOOD GAS CONTROL PRODUCTS

Applicant Alko Diagnostic Corp.

K number K884266

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JPK 1989-03-23

NE-CHECK

Applicant Streck Laboratories, Inc.

K number K890767

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JPK 1989-02-27

CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE

Applicant R&D Systems, Inc.

K number K890749

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JPK 1988-03-01

MSI-DIFF PLUS

Applicant Medical Specialties, Inc.

K number K880270

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JPK 1987-09-29

QBC VENOUS BLOOD CONTROL/MULTIPLE

Applicant R&D Systems, Inc.

K number K873354

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JPK 1987-03-25

MSI HEMATOLOGY CONTROL +

Applicant Medical Specialties, Inc.

K number K871067

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JPK 1986-10-29

HEMATALL-C PLUS HEMATOLOGY CONTROLS

Applicant Fisher Scientific Co., LLC

K number K863224

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