Immage Immunochemistry System High Sensitivity C-Reactive Protein (CRPH) Reagent
FDA 510(k) K010236 · Beckman Coulter, Inc.
510(k) numberK010236
Submission
- Device name
- Immage Immunochemistry System High Sensitivity C-Reactive Protein (CRPH) Reagent
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- January 25, 2001
- Decision date
- April 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
Other 510(k)s with product code DCK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2)DCK · Traditional | Kamiya Biomedical Company, LLC | 04/18/2025SE |
| K201256 | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeDCK · Traditional | Procise Diagnostics | 11/04/2022SE |
| K192028 | Yumizen C1200 CRPDCK · Traditional | Horiba Abx SAS | 06/25/2020SE |
| K192118 | CRP VarioDCK · Special | SENTINEL CH. SpA | 11/08/2019SE |
| K191993 | Yumizen C1200 CRPDCK · Traditional | Horiba Abx SAS | 10/03/2019SE |
| K160712 | VITROS Chemistry Products hsCRP ReagentDCK · Traditional | Ortho Clinical Diagnostics | 07/14/2017SE |
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and…DCK · Traditional | Orion Diagnostica, OY | 03/10/2016SE |
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7DCK · Special | Ortho Clinical Diagnostics | 09/24/2015SE |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…DCK · Traditional | Qualigen, Inc. | 01/07/2015SE |
| K121558 | Diazyme Hscrp Poc Test KitDCK · Traditional | Diazyme Laboratories | 09/21/2012SE |
More from Diazyme Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was Immage Immunochemistry System High Sensitivity C-Reactive Protein (CRPH) Reagent cleared by the FDA?
Immage Immunochemistry System High Sensitivity C-Reactive Protein (CRPH) Reagent (K010236) received a 510(k) decision of Substantially Equivalent on April 5, 2001, 70 days after the submission was received.
What is the product code of K010236?
The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.