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510(k) K981638

Device
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
Applicant
BECKMAN COULTER, INC.
510(k) number
K981638
Product code
DCK  
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-12
Date received
1998-05-08
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANNETTE HELLIE
Address
200 S. Kraemer Blvd.,M/S W-104 Box 8000 Brea CA US 92822 92822

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K142993QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go InstrumentOrion Diagnostica, OY2016-03-10
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

Legacy Summary#

summary

FDA Review#

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