Eye Spot CRP Test
FDA 510(k) K932180 · J.S. Medical Assoc.
510(k) numberK932180
Submission
- Device name
- Eye Spot CRP Test
- Applicant
- J.S. Medical Assoc.
Natick, MA, US - Received
- May 5, 1993
- Decision date
- August 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K932752 | Visi-SpotJTO · Traditional | 11/05/1993SE |
| K932688 | Eye Spot Im TestKTN · Traditional | 09/08/1993SE |
| K932551 | Accutex Im Latex TestKTN · Traditional | 08/09/1993SE |
| K926112 | Accutex Beta-Hcg TestJHJ · Traditional | 07/28/1993SE |
| K924332 | Accutex CRP Latex TestDCK · Traditional | 12/07/1992SE |
| K924247 | Accutex Aso Latex TestGTQ · Traditional | 12/07/1992SE |
| K924036 | Accutex Rheumatiod Factor (RF) Latex TestDHR · Traditional | 12/01/1992SE |
| K924248 | Accutex Sle Latex TestLJM · Traditional | 11/02/1992SE |
| K924037 | Accutex Im RBC TestKTN · Traditional | 11/02/1992SE |
| K912717 | J&S Uibc ReagentsJMO · Traditional | 09/25/1991SE |
Questions and answers
When was Eye Spot CRP Test cleared by the FDA?
Eye Spot CRP Test (K932180) received a 510(k) decision of Substantially Equivalent on August 23, 1993, 110 days after the submission was received.
What is the product code of K932180?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.