FDA.reportPublic FDA data

510(k) K061802

Device
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH
Applicant
DADE BEHRING, INC.
510(k) number
K061802
Product code
NQD  
Decision
Substantially Equivalent (SESE)
Decision date
2006-09-11
Date received
2006-06-27
Regulation
866.5270
Classification name
Cardiac C-reactive Protein, Antigen, Antiserum, And Control
Medical specialty
Immunology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KATHLEEN DRAY-LYONS
Address
P.O. Box 6101 Newark DE US 19714 19714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NQD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics2026-04-02
K233242Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc.2024-01-18
K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH2022-12-16
K173833CRP VarioSENTINEL CH. SpA2018-09-27
K081294ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORSSiemens Healthcare Diagnostics, Inc.2008-07-29
K071002IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENTBeckman Coulter, Inc.2007-06-21
K070626SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENTBeckman Coulter, Inc.2007-05-04
K071017IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)Siemens Medical Solutions Diagnostics2007-05-02
K062924STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAKDade Behring, Inc.2006-12-26
K063057IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRPDiagnostic Products Corporation2006-12-22
K060369STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAKDade Behring, Inc.2006-05-04
K053603C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTSRoche Diagnostics Corp.2006-02-09
K053109DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGEDade Behring, Inc.2005-12-23
K051564OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGHOlympus America, Inc.2005-08-22
K042485TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)Roche Diagnostics Corp.2004-10-29

Legacy Summary#

summary

FDA Review#

Decision Summary