Product code DCN— Immunology
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
- Classification name
- System, Test, C-Reactive Protein
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Total cleared
- 70
- First cleared
- Most recent
Market context for product code DCN
FDA has cleared devices under product code DCN between 1977 and 2023, filed by 53 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2023
- 2020
- 2018
- 2017
- 2012
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
Top applicants under product code DCN
Recent clearances under product code DCN
- K232624 — CardioPhase® hsCRP
- K221119 — RCRP Flex reagent cartridge
- K192072 — Tina-quant C-Reactive Protein IV
- K180099 — Optilite High Sensitivity C-Reactive Protein Kit
- K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
- K171498 — MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
- K161982 — C-Reactive Protein Kit for use on SPAPLUS
- K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
- K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
- K083444 — C-REACTIVE PROTEIN (LATEX)
- K083412 — PATHFAST HSCRP
- K083040 — S-TEST C-REACTIVE PROTEIN (CRP)
- K072658 — ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
- K073277 — ROCHE-CREACTIVE PROTEIN (LATEX)
- K062981 — I-CHROMA CRP TEST
- K061825 — DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
- K050713 — DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
- K040030 — BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
- K032336 — TINA-QUANT CRP (LATEX)
- K030899 — C-REACTIVE PROTEIN (CRP)
- K022690 — PAROS CRP
- K021757 — CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
- K021572 — SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR
- K021882 — CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
- K020603 — CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
- K011855 — WAMPOLE HS-CRP ELISA
- K012337 — BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
- K011958 — CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
- K003400 — CRP HS TEST SYSTEM
- K003419 — RCRP FLEX REAGENT CARTRIDGE
- K003342 — WAKO CRP-UL, CRP-UL CALIBRATOR SET
- K003372 — IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
- K002918 — OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
- K991372 — CRP
- K990825 — REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
- K974429 — RAPET CRP
- K954537 — OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
- K955042 — CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM
- K935075 — SPQ CRP CONTROL LEVEL II
- K932180 — EYE SPOT CRP TEST
- K910535 — SYNCHRON C-REACTIVE PROTEIN REAGENT
- K910686 — RHEUMAJET CRP
- K904497 — CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST
- K903853 — RAPITEX (R) CRP NEW
- K902593 — RAICHEM(TM) SPIA(TM) CRP REAGENT
- K896272 — QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
- K892231 — V-TREND TARGET CRP TEST
- K885001 — QM300 PCR ANTIBODY PACK
- K883515 — DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
- K882374 — WAKO(TM) CRP
- K880728 — KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK
- K872539 — EUROGENETICS CRP ELISA
- K860679 — IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN
- K854819 — CPR SLIDE EIKEN
- K855057 — LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)
- K841265 — TAGO DIFFU-GEN C-REACTIVE PROTEIN
- K840699 — CRP SLIDE TEST KIT
- K834584 — NABI CRP-Q.S. TEST
- K834390 — IMMUNO-CRP
- K831465 — CRP-CHECK
- K831362 — TESTCORP CRP
- K831364 — TESTCORP RA
- K821388 — SERO/TEX CRP TEST
- K821413 — EMIT C-REACTIVE PROTEIN ASSAY
- K812881 — IMMUNEX CRP
- K811374 — BI-CRP LATEX TEST
- K810862 — CRP SLIDE
- K790716 — ANTISERUM TO HUMAN C-REACTIVE PROTEINS
- K771535 — LAS-R HUMAN CRP TEST
- K771139 — CRP-WELLCOTEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.