DCN · Class II · 21 CFR 866.5270

FDA Product Code DCN: System, Test, C-reactive Protein

Leading manufacturers include Roche Diagnostics Corp., Good Biotech Corp. and Dade Behring, Inc..

70
Total
70
Cleared
94d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared System, Test, C-reactive Protein Devices (Product Code DCN)

70 devices
1–24 of 70
Cleared Nov 27, 2023
CardioPhase® hsCRP
K232624
Siemens Healthcare Diagnostic Products GmbH
Immunology · 90d
Cleared Mar 17, 2023
RCRP Flex reagent cartridge
K221119
Siemens Healthcare Diagnostics, Inc.
Immunology · 333d
Cleared Feb 21, 2020
Tina-quant C-Reactive Protein IV
K192072
Roche Diagnostics Operations (Rdo)
Immunology · 203d
Cleared Oct 12, 2018
Optilite High Sensitivity C-Reactive Protein Kit
K180099
The Binding Site Group , Ltd.
Chemistry · 269d
Cleared Feb 28, 2018
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
K172868
The Binding Site Group , Ltd.
Immunology · 161d
Cleared Jan 12, 2018
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498
Meso Scale Diagnostics, LLC
Immunology · 234d
Cleared Apr 05, 2017
C-Reactive Protein Kit for use on SPAPLUS
K161982
The Binding Site Group
Immunology · 260d
Cleared Aug 17, 2012
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
K113809
Hitachi Chemical Diagnostics, Inc.
Immunology · 238d
Cleared Jan 15, 2010
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
K091052
Abaxis, Inc.
Immunology · 277d
Cleared Mar 18, 2009
C-REACTIVE PROTEIN (LATEX)
K083444
Roche Diagnostics Corp.
Immunology · 117d
Cleared Mar 09, 2009
PATHFAST HSCRP
K083412
Mitsubishi Kagaku Iatron
Chemistry · 111d
Cleared Jan 30, 2009
S-TEST C-REACTIVE PROTEIN (CRP)
K083040
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 108d
Cleared Apr 01, 2008
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
K072658
Siemens Medical Solutions Diagnostics
Immunology · 194d
Cleared Mar 06, 2008
ROCHE-CREACTIVE PROTEIN (LATEX)
K073277
Roche Diagnostics Corp.
Immunology · 106d
Cleared Jul 13, 2007
I-CHROMA CRP TEST
K062981
Boditech Diagnostics, Inc.
Chemistry · 287d
Cleared Sep 06, 2006
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
K061825
Dade Behring, Inc.
Chemistry · 70d
Cleared Jun 06, 2005
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
K050713
Good Biotech Corp.
Chemistry · 80d
Cleared Jun 16, 2004
BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
K040030
Biocheck, Inc.
Immunology · 161d
Cleared Aug 05, 2003
TINA-QUANT CRP (LATEX)
K032336
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Jul 02, 2003
C-REACTIVE PROTEIN (CRP)
K030899
Abbott Laboratories
Chemistry · 100d
Cleared Dec 23, 2002
PAROS CRP
K022690
Horiba, Ltd.
Immunology · 132d
Cleared Jul 29, 2002
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
K021757
Good Biotech Corp.
Immunology · 61d
Cleared Jul 19, 2002
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572
Beckman Coulter, Inc.
Immunology · 66d
Cleared Jul 11, 2002
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
K021882
Good Biotech Corp.
Immunology · 34d

About Product Code DCN - Regulatory Context

510(k) Submission Activity

70 total 510(k) submissions under product code DCN since 1977, with 70 receiving FDA clearance (average review time: 94 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.