C-Reactive Protein, Antigen, Antiserum, And Control

FDA product code DCK · 124 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5270
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-03 – 2025-04-18

DCK 2025-04-18

K-ASSAY CRP (Ver.2)

Applicant Kamiya Biomedical Company, LLC

K number K242170

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DCK 2022-11-04

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge

Applicant Procise Diagnostics

K number K201256

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DCK 2020-06-25

Yumizen C1200 CRP

Applicant HORIBA ABX SAS

K number K192028

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DCK 2019-11-08

CRP Vario

Applicant SENTINEL CH. SpA

K number K192118

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DCK 2019-10-03

Yumizen C1200 CRP

Applicant HORIBA ABX SAS

K number K191993

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DCK 2017-07-14

VITROS Chemistry Products hsCRP Reagent

Applicant Ortho Clinical Diagnostics

K number K160712

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DCK 2016-03-10

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

Applicant Orion Diagnostica, OY

K number K142993

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DCK 2012-09-21

DIAZYME HSCRP POC TEST KIT

Applicant Diazyme Laboratories

K number K121558

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DCK 2011-04-27

DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET

Applicant Diazyme Laboratories

K number K103557

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DCK 2006-09-29

ABX PENTRA 400 : CRP

Applicant Horiba Abx

K number K061138

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DCK 2006-04-28

CRP-ADVANCE ASSAY, MODELS 250-20, 250-25

Applicant Diagnostic Chemicals , Ltd.

K number K060139

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DCK 2006-02-09

NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT

Applicant Clinical Data, Inc.

K number K052591

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DCK 2005-08-08

CRP DIAGNOSTIC ASSAY

Applicant Sentinel Ch. Srl

K number K050836

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DCK 2004-10-14

WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

Applicant Stanbio Laboratory

K number K041155

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DCK 2004-09-24

QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE

Applicant Orion Diagnostica, OY

K number K042442

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DCK 2004-06-25

N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET

Applicant Genzyme Corp.

K number K040241

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DCK 2004-06-18

CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)

Applicant Cholestech Corp.

K number K040579

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DCK 2003-12-19

QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2

Applicant Instrumentation Laboratory CO

K number K032663

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DCK 2003-10-10

ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL

Applicant Orion Diagnostica, Div. Orion Corp.

K number K031607

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DCK 2003-09-30

EXTENDED RANGE HS CRP KIT, CAT NO:9200

Applicant Reference Diagnostics, Inc.

K number K030044

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DCK 2003-06-06

WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET

Applicant Wako Chemicals USA, Inc.

K number K024280

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DCK 2003-06-02

CRP-LATEX (II)X2 SEIKEN ASSAY KIT

Applicant Denka Seiken Co., Ltd.

K number K030545

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DCK 2003-03-18

VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7

Applicant Ortho-Clinical Diagnostics, Inc.

K number K030626

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DCK 2003-02-04

K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR

Applicant Kamiya Biomedical Co.

K number K023828

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DCK 2002-12-23

HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS

Applicant Instrumentation Laboratory CO

K number K023269

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DCK 2002-12-03

ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257

Applicant Orion Diagnostica, Div. Orion Corp.

K number K022176

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DCK 2002-08-14

K-ASSAY HS-CRP CONTROLS

Applicant Kamiya Biomedical Co.

K number K022486

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DCK 2002-07-29

RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM

Applicant Hemagen Diagnostics, Inc.

K number K021194

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DCK 2002-06-27

RDI HS CRP KIT

Applicant Reference Diagnostics, Inc.

K number K021609

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DCK 2002-05-14

NYCOCARD CRP

Applicant Primus Corp.

K number K013787

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DCK 2002-01-07

NYCOCARD CRP CONTROL

Applicant Primus Corp.

K number K014084

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DCK 2001-07-20

BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119

Applicant Biocheck, Inc.

K number K003851

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DCK 2001-05-29

SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT

Applicant Beckman Coulter, Inc.

K number K010597

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DCK 2001-05-16

K-ASSAY HS-CRP CONTROLS

Applicant Kamiya Biomedical Co.

K number K011079

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DCK 2001-04-05

IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT

Applicant Beckman Coulter, Inc.

K number K010236

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DCK 2000-10-25

K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE

Applicant Kamiya Biomedical Co.

K number K002558

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DCK 2000-10-13

C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K002651

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DCK 2000-08-24

C-REACTIVE PROTEIN ANTISERUM KIT

Applicant The Binding Site, Ltd.

K number K001636

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DCK 2000-08-04

RANDOX C-REACTIVE PROTEIN

Applicant Randox Laboratories, Ltd.

K number K001009

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DCK 1999-10-25

DADE BEHRING N HIGH SENSITIVITY CRP ASSAY

Applicant Dade Behring, Inc.

K number K991385

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DCK 1999-09-13

K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B

Applicant Kamiya Biomedical Co.

K number K992312

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DCK 1999-09-13

K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC

Applicant Kamiya Biomedical Co.

K number K992311

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DCK 1999-05-14

K-ASSAY CRP

Applicant Kamiya Biomedical Co.

K number K991224

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DCK 1999-05-11

K-ASSAY CRP CALIBRATOR SET

Applicant Kamiya Biomedical Co.

K number K991210

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DCK 1999-05-03

ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT

Applicant Beckman Coulter, Inc.

K number K990704

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DCK 1999-04-06

IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5

Applicant Diagnostic Products Corp.

K number K990886

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DCK 1999-01-28

IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5

Applicant Diagnostic Products Corp.

K number K984132

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DCK 1998-11-09

C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100

Applicant Diagnostic Systems Laboratories, Inc.

K number K981871

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DCK 1998-08-18

ROCHE CRP T CONTROL N

Applicant Roche Diagnostic Systems, Inc.

K number K982087

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DCK 1998-06-12

IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT

Applicant Beckman Coulter, Inc.

K number K981638

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DCK 1998-02-09

UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE

Applicant United Biotech, Inc.

K number K973692

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DCK 1997-11-24

SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT

Applicant Beckman Instruments, Inc.

K number K974050

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DCK 1997-08-01

CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST

Applicant Trinity Laboratories, Inc.

K number K972160

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DCK 1997-07-03

N-ASSAY TIA MULTI CRP CALIBRATOR SET

Applicant Crestat Diagnostics, Inc.

K number K965110

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DCK 1996-12-18

C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT

Applicant Polymedco, Inc.

K number K962049

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DCK 1996-11-25

C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST

Applicant Teco Diagnostics

K number K962019

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DCK 1996-11-04

IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT

Applicant Beckman Instruments, Inc.

K number K963061

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DCK 1996-08-19

QUALITROL CRP CONTROL SET

Applicant Consolidated Technologies, Inc.

K number K961829

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DCK 1996-07-11

N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2

Applicant Behring Diagnostics, Inc.

K number K962373

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DCK 1996-07-10

N LATEX CRP MONO REAGENT

Applicant Behring Diagnostics, Inc.

K number K962523

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DCK 1996-04-19

CRP-LATEX SEIKEN XR REAGENT SYSTEM

Applicant Globe Management Support, Inc.

K number K960702

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DCK 1996-03-12

HEMAGEN CRP 150 KIT (EIA METHOD)

Applicant Hemagen Diagnostics, Inc.

K number K960324

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DCK 1996-02-16

WAKO AUTOKIT CRP NEW

Applicant Wako Chemicals USA, Inc.

K number K955156

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DCK 1995-12-18

C-REACTIVE PROTEIN LATEX KIT

Applicant Randox Laboratories, Ltd.

K number K954447

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DCK 1995-09-15

LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM

Applicant International Enzymes, Inc.

K number K953926

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DCK 1995-08-01

HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)

Applicant The Binding Site, Ltd.

K number K953207

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DCK 1995-07-31

C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR

Applicant Randox Laboratories, Ltd.

K number K953212

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DCK 1995-07-31

EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K953197

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DCK 1995-04-20

MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2

Applicant Medical Analysis Systems, Inc.

K number K951057

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DCK 1995-03-09

DUPONT DIMENSION C-REACTIVE PROTEIN METHOD

Applicant Dupont Medical Products

K number K945280

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DCK 1995-02-10

LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2

Applicant Clinical Controls, Inc.

K number K946050

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DCK 1994-10-03

N/T RHEUMATOLOGY CONTROL SL/1, SL/2

Applicant Behring Diagnostics, Inc.

K number K944375

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DCK 1994-10-03

HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)

Applicant Hemagen Diagnostics, Inc.

K number K944288

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DCK 1993-03-10

TINA-QUANT CRP

Applicant Boehringer Mannheim Corp.

K number K930621

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DCK 1992-12-07

ACCUTEX CRP LATEX TEST

Applicant J.S. Medical Assoc.

K number K924332

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DCK 1992-12-07

VIGIL II

Applicant Beckman Instruments, Inc.

K number K920845

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DCK 1992-12-01

PULSE CRP TEST

Applicant Pulse Scientific, Inc.

K number K923768

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DCK 1992-10-05

TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL

Applicant Simplicity Diagnostics, Inc.

K number K922722

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DCK 1992-01-15

TIA CRP TEST KIT

Applicant Crestat Diagnostics, Inc.

K number K914155

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DCK 1991-07-22

HUMAN C-REACTIVE PROTEIN RID KIT

Applicant The Binding Site, Ltd.

K number K905633

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DCK 1990-10-01

RHEUMAGEN CRP T-CONTROL

Applicant Biokit USA, Inc.

K number K904312

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DCK 1989-09-27

WAKO(TM) AUTOKIT CRP

Applicant Wako Chemicals USA, Inc.

K number K895598

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DCK 1989-08-10

SCANLISA HUMAN CRP ELISA KIT

Applicant Immuntech A/S

K number K894573

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DCK 1989-05-09

SPQ TM TEST SYSTEM II FOR CRP

Applicant Atlantic Antibodies

K number K892526

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DCK 1989-05-09

TECHNICON DPA-1 (TM) CRP METHOD

Applicant Technicon Instruments Corp.

K number K892198

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DCK 1989-04-14

C REACTIVE PROTEIN LIQUID

Applicant Ampcor, Inc.

K number K892146

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DCK 1989-04-14

QUIK-DOT C REACTIVE PROTEIN

Applicant Ampcor, Inc.

K number K892119

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DCK 1989-02-17

V-TREND TARGET CRP TEST

Applicant Texas Immunology, Inc.

K number K890423

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DCK 1988-10-19

DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K884101

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DCK 1988-09-07

ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST

Applicant Amtec Diagnostics International, Inc.

K number K882998

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DCK 1988-03-30

KALLESTAD QM300 CALIBRATOR C PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K880729

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DCK 1988-03-25

KALLESTAD QM2/QM300 CONTROL C PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K880730

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DCK 1988-03-21

VISION(R) CRP

Applicant Abbott Laboratories

K number K875345

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DCK 1988-02-25

MODIFIED CRP LATEX TEST

Applicant Sclavo, Inc.

K number K880016

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DCK 1987-10-13

CRP

Applicant Unipath , Ltd.

K number K873865

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DCK 1987-06-15

TINA-QUANT [A] CRP

Applicant Boehringer Mannheim Corp.

K number K871895

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DCK 1987-05-06

PRECIMAT(R) CRP

Applicant Boehringer Mannheim Corp.

K number K871055

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DCK 1987-03-16

VISION(TM) CRP

Applicant Abbott Laboratories

K number K864131

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DCK 1986-10-15

C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS

Applicant Technicon Instruments Corp.

K number K863628

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DCK 1986-09-26

ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K863329

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