DCK — C-Reactive Protein, Antigen, Antiserum, And Control Class II
FDA Device Classification
Classification Details
- Product Code
- DCK
- Device Class
- Class II
- Regulation Number
- 866.5270
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K242170 | kamiya biomedical company | K-ASSAY CRP (Ver.2) | April 18, 2025 |
| K201256 | procise diagnostics | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge | November 4, 2022 |
| K192028 | horiba abx | Yumizen C1200 CRP | June 25, 2020 |
| K192118 | sentinel ch | CRP Vario | November 8, 2019 |
| K191993 | horiba abx | Yumizen C1200 CRP | October 3, 2019 |
| K160712 | ortho clinical diagnostics | VITROS Chemistry Products hsCRP Reagent | July 14, 2017 |
| K142993 | orion diagnostica | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, | March 10, 2016 |
| K152433 | ortho clinical diagnostics | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 | September 24, 2015 |
| K141689 | qualigen | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Rea | January 7, 2015 |
| K121558 | diazyme laboratories | DIAZYME HSCRP POC TEST KIT | September 21, 2012 |
| K103557 | diazyme laboratories | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET | April 27, 2011 |
| K061138 | horiba abx | ABX PENTRA 400 : CRP | September 29, 2006 |
| K060139 | diagnostic chemicals | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 | April 28, 2006 |
| K052591 | clinical data | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT | February 9, 2006 |
| K050836 | sentinel ch | CRP DIAGNOSTIC ASSAY | August 8, 2005 |
| K041155 | stanbio laboratory | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY | October 14, 2004 |
| K042442 | orion diagnostica | QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODE | September 24, 2004 |
| K040241 | genzyme | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET | June 25, 2004 |
| K040579 | cholestech | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) | June 18, 2004 |
| K032663 | instrumentation laboratory | QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY C | December 19, 2003 |