CRP Slide
FDA 510(k) K810862 · Syn-Kit, Inc.
510(k) numberK810862
Submission
- Device name
- CRP Slide
- Applicant
- Syn-Kit, Inc.
Mchenry, IL, US - Received
- March 31, 1981
- Decision date
- April 8, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DCN – System, Test, C-Reactive Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
Other 510(k)s with product code DCN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232624 | CardioPhase® hsCRPDCN · Traditional | Siemens Healthcare Diagnostic Products GmbH | 11/27/2023SE |
| K221119 | RCRP Flex reagent cartridgeDCN · Special | Siemens Healthcare Diagnostics, Inc. | 03/17/2023SE |
| K192072 | Tina-quant C-Reactive Protein IVDCN · Traditional | Roche Diagnostics Operations (Rdo) | 02/21/2020SE |
| K180099 | Optilite High Sensitivity C-Reactive Protein KitDCN · Traditional | The Binding Site Group , Ltd. | 10/12/2018SE |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite…DCN · Traditional | The Binding Site Group , Ltd. | 02/28/2018SE |
| K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentDCN · Traditional | Meso Scale Diagnostics, LLC | 01/12/2018SE |
| K161982 | C-Reactive Protein Kit for use on SPAPLUSDCN · Traditional | The Binding Site Group | 04/05/2017SE |
| K113809 | Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP)DCN · Traditional | Hitachi Chemical Diagnostics, Inc. | 08/17/2012SE |
| K091052 | Piccolo C-Reactive Protein (CRP) Test SystemDCN · Traditional | Abaxis, Inc. | 01/15/2010SE |
| K083444 | C-Reactive Protein (Latex)DCN · Traditional | Roche Diagnostics Corp. | 03/18/2009SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K861098 | Seroiden Strepto Kit 'Eiken'GTZ · Traditional | 08/12/1986SE |
| K861631 | Slide Culture U 'Eiken'JXA · Traditional | 06/10/1986SE |
| K854819 | CPR Slide EikenDCN · Traditional | 02/26/1986SE |
| K854820 | Ra 80 EikenDHR · Traditional | 01/17/1986SE |
| K853276 | Aso Slide EikenGTQ · Traditional | 08/20/1985SE |
| K843760 | Uropaper Eiken GJIL · Traditional | 12/18/1984SE |
| K843759 | Uropaper Eiken HagJIL · Traditional | 12/18/1984SE |
| K843758 | Uropaper Eiken GKJIL · Traditional | 12/18/1984SE |
| K843757 | Uropaper Eiken AGJIL · Traditional | 12/18/1984SE |
| K843756 | Uropaper Eiken 5JIL · Traditional | 12/18/1984SE |
Questions and answers
When was CRP Slide cleared by the FDA?
CRP Slide (K810862) received a 510(k) decision of Substantially Equivalent on April 8, 1981, 8 days after the submission was received.
What is the product code of K810862?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.