DCK — C-Reactive Protein, Antigen, Antiserum, And Control Class II
FDA product code DCK covers "C-Reactive Protein, Antigen, Antiserum, And Control", a Class II medical device regulated under 21 CFR 866.5270. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |