Nabi Crp-Q.S. Test
FDA 510(k) K834584 · Intl. Diagnostic, Inc.
510(k) numberK834584
Submission
- Device name
- Nabi Crp-Q.S. Test
- Applicant
- Intl. Diagnostic, Inc.
Mchenry, IL, US - Received
- December 29, 1983
- Decision date
- February 27, 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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| 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 |
|---|---|---|
| K841853 | Preg-Beta One Hour Tube TestJHJ · Traditional | 06/22/1984SE |
| K840833 | Preg Beta Blus SlideJHJ · Traditional | 05/30/1984SE |
| K840005 | Nabi Rf-Q.S. TestDHR · Traditional | 02/13/1984SE |
| K802343 | Pregna B-Anti Human Chorionic GonadotroJHJ · Traditional | 10/10/1980SE |
| K780321 | Pregnancy Test Kit, Over-The-CounterLCX · Traditional | 04/04/1978SE |
Questions and answers
When was Nabi Crp-Q.S. Test cleared by the FDA?
Nabi Crp-Q.S. Test (K834584) received a 510(k) decision of Substantially Equivalent on February 27, 1984, 60 days after the submission was received.
What is the product code of K834584?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.