Tago Diffu-Gen C-Reactive Protein
FDA 510(k) K841265 · Tago, Inc.
510(k) numberK841265
Submission
- Device name
- Tago Diffu-Gen C-Reactive Protein
- Applicant
- Tago, Inc.
Mchenry, IL, US - Received
- March 26, 1984
- Decision date
- May 22, 1984
- 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
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| 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 |
|---|---|---|
| K841734 | Tago Fiffu-Gen, OrosomucoidLKL · Traditional | 06/01/1984SE |
| K834218 | Diffu-Gen Apolipoprotein A-I Radial -MSJ · Traditional | 05/11/1984SE |
| K840404 | Diffu-Gen Haptoglobin Radial ImmunoDAD · Traditional | 03/09/1984SE |
| K833129 | Tago Diffu-Gen-Apolipoprotein B-100MSJ · Traditional | 11/21/1983SE |
| K830611 | Ra Screening TestDHR · Traditional | 03/24/1983SE |
| K830531 | Mono Screening TestKTN · Traditional | 03/17/1983SE |
| K830156 | HCG Screening TestJHJ · Traditional | 02/09/1983SE |
Questions and answers
When was Tago Diffu-Gen C-Reactive Protein cleared by the FDA?
Tago Diffu-Gen C-Reactive Protein (K841265) received a 510(k) decision of Substantially Equivalent on May 22, 1984, 57 days after the submission was received.
What is the product code of K841265?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.