Crp-Check
FDA 510(k) K831465 · Diagnostic Technology, Inc.
510(k) numberK831465
Submission
- Device name
- Crp-Check
- Applicant
- Diagnostic Technology, Inc.
Mchenry, IL, US - Received
- May 6, 1983
- Decision date
- June 8, 1983
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K896378 | Lyme-Check(Tm) Test KitLSR · Traditional | 11/05/1991SE |
| K903612 | Ebv/Ea-Check TM Test KitLSE · Traditional | 10/16/1990SE |
| K891542 | Ebna-Check(Tm) Test KitLLM · Traditional | 06/20/1989SE |
| K890819 | Hsv-Check(Tm) Test KitHIS · Traditional | 06/20/1989SE |
| K890639 | Resubmitted Ebv/Igm-Check Test KitLJN · Traditional | 06/20/1989SE |
| K871373 | Ebv-Check(Tm) Test Kit (Igg)GNP · Traditional | 06/25/1987SE |
| K864128 | Chlamydia-Check(Tm) Direct & Culture Confir. KitLJP · Traditional | 04/29/1987SE |
| K863408 | Ebv/Vca-Check(Tm) Antigen SlidesGNP · Traditional | 11/28/1986SE |
| K860586 | PHA-2 Conversion Program for Platelet AnalysisGKL · Traditional | 05/07/1986SE |
| K860166 | Picoscale Blood Cell Counter, Model PS-5GKL · Traditional | 04/04/1986SE |
Questions and answers
When was Crp-Check cleared by the FDA?
Crp-Check (K831465) received a 510(k) decision of Substantially Equivalent on June 8, 1983, 33 days after the submission was received.
What is the product code of K831465?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.