510(k) K221119

Device
RCRP Flex reagent cartridge
Applicant
Siemens Healthcare Diagnostics, Inc.
510(k) number
K221119
Product code
DCN
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-17
Date received
2022-04-18
Regulation
866.5270
Classification name
System, Test, C-Reactive Protein
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ian Thompson
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DCN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH2023-11-27
K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)2020-02-21
K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.2018-10-12
K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.2018-02-28
K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC2018-01-12
K161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group2017-04-05
K113809HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)Hitachi Chemical Diagnostics, Inc.2012-08-17
K091052PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEMAbaxis, Inc.2010-01-15
K083444C-REACTIVE PROTEIN (LATEX)Roche Diagnostics Corp.2009-03-18
K083412PATHFAST HSCRPMitsubishi Kagaku Iatron2009-03-09
K083040S-TEST C-REACTIVE PROTEIN (CRP)Alfa Wassermann Diagnostic Technologies, Inc.2009-01-30
K072658ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORSSiemens Medical Solutions Diagnostics2008-04-01
K073277ROCHE-CREACTIVE PROTEIN (LATEX)Roche Diagnostics Corp.2008-03-06
K062981I-CHROMA CRP TESTBoditech Diagnostics, Inc.2007-07-13
K061825DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGHDade Behring, Inc.2006-09-06