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Panels › Hematology › Product code JPK · Class 2

Mixture, Hematology Quality Control

Regulation 864.8625

0510(k)s in 12 months (192 all time)
0recalls in 12 months (16 all time)
15recalls that name a 510(k)
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Top companies in JPK

Company510(k)sRecalls
R&D Systems, Inc.452
Streck Laboratories, Inc.230
Streck120
Beckman Coulter, Inc.100
Coulter Electronics, Inc.80
Bhp Diagnostix, Inc.70
Clinical Diagnostic Solutions, Inc.16
Hematronix, Inc.60
American Dade50
Coulter Corp.50
Decided510(k)Device and applicantCode
Dec 22, 2016K160590XN CHECK
Streck
JPK
Dec 22, 2016K160588XN CHECK BF
Streck
JPK
Dec 22, 2016K160586XN-L CHECK
Streck
JPK
Sep 1, 2016K160606BC-5D Hematology Control
R&D Systems, Inc.
JPK
Dec 5, 2014K141964XN CHECK
Streck
JPK
Dec 5, 2014K141957XN CHECK BF
Streck
JPK
Jul 24, 2013K130962R&D 5D RETIC HEMATOLOGY CONTROL
R&D Systems, Inc.
JPK
Oct 19, 2012K120744XN CHECK BF
Streck
JPK
Oct 19, 2012K120742XN CHECK
Streck
JPK
Apr 28, 2011K101578R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
R&D Systems, Inc.
JPK
Dec 21, 2010K100790COULTER LIN-X LINEARITY CONTROL, MODEL A81196
Beckman Coulter, Inc.
JPK
Nov 18, 2010K100607COULTER 4C-EX 300 CELL CONTROL
Beckman Coulter, Inc.
JPK
Aug 2, 2010K091303LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
Bio-Rad Laboratories
JPK
Jan 29, 2010K100050R & D SYSTEMS XERET HEMATOLOGY CONTROL
R&D Systems, Inc.
JPK
Oct 28, 2009K091433R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
R&D Systems, Inc.
JPK
Mar 27, 2009K090201UA-CELLULAR FOR IQ
Streck
JPK
Feb 3, 2009K082162COULTER BODY FLUID CONTROL
Beckman Coulter, Inc.
JPK
Jan 21, 2009K081822COULTER 6C CELL CONTROL, MODELS 628027 & A59925
Beckman Coulter, Inc.
JPK
Jan 16, 2009K081641COULTER LIN-X LINEARITY CONTROL
Beckman Coulter, Inc.
JPK
Dec 27, 2007K073178HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
R&D Systems, Inc.
JPK
Nov 26, 2007K072846CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
R&D Systems, Inc.
JPK
Nov 20, 2007K072268HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
R&D Systems, Inc.
JPK
Aug 20, 2007K072096CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
R&D Systems, Inc.
JPK
Feb 23, 2007K070199RETIC-CHEX LINEARITY FOR BC
Streck
JPK
Dec 14, 2006K063218E-CHECK (XE)
Streck
JPK
Jul 10, 2006K061511R&D CBC-3D + CRP HEMATOLOGY CONTROL
R&D Systems, Inc.
JPK
Jun 2, 2006K061320R&D LH-NRBC HEMATOLOGY CONTROL
R&D Systems, Inc.
JPK
May 17, 2006K061064COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
Beckman Coulter, Inc.
JPK
Mar 28, 2006K060464COULTER 5C CELL CONTROL
Beckman Coulter, Inc.
JPK
Jan 13, 2006K053362CELL-CHEX AUTO
Streck
JPK
Aug 17, 2005K051706IQ BODY FLUIDS CONTROL
Streck
JPK
Jul 12, 2005K051339R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
R&D Systems, Inc.
JPK
Jun 1, 2005K050721ABX ERYTROL
Horiba Abx, FR
JPK
Nov 5, 2004K042836LIQUICHEK RETICULOCYTE CONTROL (A)
Bio-Rad
JPK
Oct 19, 2004K042587RETIC-CHEX FOR CELL-DYN
Streck Laboratories, Inc.
JPK
Oct 14, 2004K042336METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
Bio-Rad Laboratories, Inc.
JPK
Sep 1, 2004K042094R&D CBC-XE HEMATOLOGY CONTROL
R&D Systems, Inc.
JPK
Jun 28, 2004K041457LIQUICHEK HEMATOLOGY CONTROL (A)
Bio-Rad
JPK
Jan 14, 2003K024173CDS 3-PD HEMATOLOGY CONTROLS
Clinical Diagnostic Solutions, Inc.
JPK
Sep 24, 2002K022968ADVIA TESTPOINT CSF CONTROL
Bayer Diagnostics Corp.
JPK
Jun 25, 2002K021922MODIFICATION TO PARA 5X
Streck Laboratories, Inc.
JPK
Feb 6, 2002K020229R & D BODY FLUID CONTROL
R&D Systems, Inc.
JPK
Jan 22, 2002K013898R&D RET-LINE KIT
R&D Systems, Inc.
JPK
Dec 13, 2001K013842IMMUNO-TROL LOW CELLS
Beckman Coulter, Inc.
JPK
Jun 26, 2001K011410PARA 5X
Streck Laboratories, Inc.
JPK
May 11, 2001K010470R & D 4K RETIC
R&D Systems, Inc.
JPK
Apr 3, 2001K010461ADVIA RETIC PLUS
R&D Systems, Inc.
JPK
Mar 23, 2001K010598SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
Quantimetrix Corp.
JPK
Mar 16, 2001K010409CBC-SF
R&D Systems, Inc.
JPK
Feb 7, 2001K0100665C-ES CELL CONTROL, MODELS 7547191, 7547192
Beckman Coulter, Inc.
JPK

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