Product code DCK— Immunology
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
- Classification name
- C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Total cleared
- 126
- First cleared
- Most recent
Market context for product code DCK
FDA has cleared devices under product code DCK between 1976 and 2025, filed by 76 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2022
- 2020
- 2019
- 2017
- 2016
- 2015
- 2012
- 2011
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
Top applicants under product code DCK
Recent clearances under product code DCK
1–100 of 126- K242170 — K-ASSAY CRP (Ver.2)
- K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
- K192028 — Yumizen C1200 CRP
- K192118 — CRP Vario
- K191993 — Yumizen C1200 CRP
- K160712 — VITROS Chemistry Products hsCRP Reagent
- K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
- K152433 — VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
- K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
- K121558 — DIAZYME HSCRP POC TEST KIT
- K103557 — DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
- K061138 — ABX PENTRA 400 : CRP
- K060139 — CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
- K052591 — NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
- K050836 — CRP DIAGNOSTIC ASSAY
- K041155 — WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
- K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE
- K040241 — N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
- K040579 — CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
- K032663 — QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
- K031607 — ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
- K030044 — EXTENDED RANGE HS CRP KIT, CAT NO:9200
- K024280 — WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
- K030545 — CRP-LATEX (II)X2 SEIKEN ASSAY KIT
- K030626 — VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
- K023828 — K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
- K023269 — HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
- K022176 — ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
- K022486 — K-ASSAY HS-CRP CONTROLS
- K021194 — RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
- K021609 — RDI HS CRP KIT
- K013787 — NYCOCARD CRP
- K014084 — NYCOCARD CRP CONTROL
- K003851 — BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119
- K010597 — SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
- K011079 — K-ASSAY HS-CRP CONTROLS
- K010236 — IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
- K002558 — K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
- K002651 — C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
- K001636 — C-REACTIVE PROTEIN ANTISERUM KIT
- K001009 — RANDOX C-REACTIVE PROTEIN
- K991385 — DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
- K992311 — K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC
- K992312 — K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
- K991224 — K-ASSAY CRP
- K991210 — K-ASSAY CRP CALIBRATOR SET
- K990704 — ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
- K990886 — IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
- K984132 — IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
- K981871 — C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
- K982087 — ROCHE CRP T CONTROL N
- K981638 — IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
- K973692 — UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
- K974050 — SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
- K972160 — CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
- K965110 — N-ASSAY TIA MULTI CRP CALIBRATOR SET
- K962049 — C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT
- K962019 — C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
- K963061 — IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
- K961829 — QUALITROL CRP CONTROL SET
- K962373 — N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
- K962523 — N LATEX CRP MONO REAGENT
- K960702 — CRP-LATEX SEIKEN XR REAGENT SYSTEM
- K960324 — HEMAGEN CRP 150 KIT (EIA METHOD)
- K955156 — WAKO AUTOKIT CRP NEW
- K954447 — C-REACTIVE PROTEIN LATEX KIT
- K953926 — LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM
- K953207 — HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)
- K953197 — EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)
- K953212 — C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
- K951057 — MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2
- K945280 — DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
- K946050 — LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2
- K944288 — HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)
- K944375 — N/T RHEUMATOLOGY CONTROL SL/1, SL/2
- K930621 — TINA-QUANT CRP
- K920845 — VIGIL II
- K924332 — ACCUTEX CRP LATEX TEST
- K923768 — PULSE CRP TEST
- K922722 — TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL
- K914155 — TIA CRP TEST KIT
- K905633 — HUMAN C-REACTIVE PROTEIN RID KIT
- K904312 — RHEUMAGEN CRP T-CONTROL
- K895598 — WAKO(TM) AUTOKIT CRP
- K894573 — SCANLISA HUMAN CRP ELISA KIT
- K892198 — TECHNICON DPA-1 (TM) CRP METHOD
- K892526 — SPQ TM TEST SYSTEM II FOR CRP
- K892119 — QUIK-DOT C REACTIVE PROTEIN
- K892146 — C REACTIVE PROTEIN LIQUID
- K890423 — V-TREND TARGET CRP TEST
- K884101 — DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
- K882998 — ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST
- K880729 — KALLESTAD QM300 CALIBRATOR C PACK
- K880730 — KALLESTAD QM2/QM300 CONTROL C PACK
- K875345 — VISION(R) CRP
- K880016 — MODIFIED CRP LATEX TEST
- K873865 — CRP
- K871895 — TINA-QUANT [A] CRP
- K871055 — PRECIMAT(R) CRP
- K864131 — VISION(TM) CRP
Data sourced from openFDA. This site is unofficial and independent of the FDA.