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510(k) K142993

Device
QuikRead Go CRP, QuikRead Go CRP Verification Set, QuikRead Go CRP Control Set, And QuikRead Go Instrument
Applicant
ORION DIAGNOSTICA OY
510(k) number
K142993
Product code
DCK  
Decision
Substantially Equivalent (SESE)
Decision date
2016-03-10
Date received
2014-10-16
Regulation
866.5270
Classification name
C-reactive Protein, Antigen, Antiserum, And Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ANJA KONTIO
Address
Kiviharjuntie 11 4 B Oulu FI 90220 90220

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DCK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC2025-04-18
K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise Diagnostics2022-11-04
K192028Yumizen C1200 CRPHORIBA ABX SAS2020-06-25
K192118CRP VarioSENTINEL CH. SpA2019-11-08
K191993Yumizen C1200 CRPHORIBA ABX SAS2019-10-03
K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics2017-07-14
K152433VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7Ortho Clinical Diagnostics2015-09-24
K141689FastPack 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 KitQualigen, Inc.2015-01-07
K121558DIAZYME HSCRP POC TEST KITDiazyme Laboratories2012-09-21
K103557DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SETDiazyme Laboratories2011-04-27
K061138ABX PENTRA 400 : CRPHoriba Abx2006-09-29
K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25Diagnostic Chemicals , Ltd.2006-04-28
K052591NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KITClinical Data, Inc.2006-02-09
K050836CRP DIAGNOSTIC ASSAYSentinel Ch. Srl2005-08-08
K041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAYStanbio Laboratory2004-10-14

Legacy Summary#

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FDA Review#

Decision Summary