510(k) K061825
- Device
- DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K061825
- Product code
- DCN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-09-06
- Date received
- 2006-06-28
- Regulation
- 866.5270
- Classification name
- System, Test, C-reactive Protein
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHLEEN DRAY-LYONS
- Address
- P.O. Box 6101 Newark DE US 19714 19714
FDA Registration Numbers#
- 9614373
- 3005174594
- 3014353045
- 2517506
- 2432235
- 3014607865
- 3006198300
- 3002806944
- 9680746
- 1649661
- 3009491259
- 2085064
- 3004493545
- 1616487
- 3010825766
- 2032682
- 3012471076
- 2029372
- 9610126
- 3003795116
- 1036362
- 2435505
- 9610806
- 2939693
- 1832216
- 2020726
- 2050012
- 9610529
- 9610987
- 2050010
- 1641328
- 3029973107
- 2250030
Source Documents#
Other 510(k) Records For Product Code DCN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232624 | CardioPhase® hsCRP | Siemens Healthcare Diagnostic Products GmbH | 2023-11-27 |
| K221119 | RCRP Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. | 2023-03-17 |
| K192072 | Tina-quant C-Reactive Protein IV | Roche Diagnostics Operations (Rdo) | 2020-02-21 |
| K180099 | Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group , Ltd. | 2018-10-12 |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls | The Binding Site Group , Ltd. | 2018-02-28 |
| K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 Instrument | Meso Scale Diagnostics, LLC | 2018-01-12 |
| K161982 | C-Reactive Protein Kit for use on SPAPLUS | The Binding Site Group | 2017-04-05 |
| K113809 | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) | Hitachi Chemical Diagnostics, Inc. | 2012-08-17 |
| K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | Abaxis, Inc. | 2010-01-15 |
| K083444 | C-REACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | 2009-03-18 |
| K083412 | PATHFAST HSCRP | Mitsubishi Kagaku Iatron | 2009-03-09 |
| K083040 | S-TEST C-REACTIVE PROTEIN (CRP) | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-01-30 |
| K072658 | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS | Siemens Medical Solutions Diagnostics | 2008-04-01 |
| K073277 | ROCHE-CREACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | 2008-03-06 |
| K062981 | I-CHROMA CRP TEST | Boditech Diagnostics, Inc. | 2007-07-13 |
Legacy Summary#
summary
FDA Review#
Decision Summary