DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR
FDA 510(k) clearance K860549 · decided 1986-06-10
Clearance details
- K-number
- K860549
- Device name
- DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-13
- Decision date
- 1986-06-10
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- DCK
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| K-ASSAY CRP (Ver.2) (K242170) | Kamiya Biomedical Company, LLC | 2025-04-18 |
| Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge (K201256) | Procise Diagnostics | 2022-11-04 |
| Yumizen C1200 CRP (K192028) | HORIBA ABX SAS | 2020-06-25 |
| CRP Vario (K192118) | SENTINEL CH. SpA | 2019-11-08 |
| Yumizen C1200 CRP (K191993) | HORIBA ABX SAS | 2019-10-03 |
| VITROS Chemistry Products hsCRP Reagent (K160712) | Ortho Clinical Diagnostics | 2017-07-14 |
| QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument (K142993) | Orion Diagnostica, OY | 2016-03-10 |
| VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (K152433) | Ortho Clinical Diagnostics | 2015-09-24 |
| FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit (K141689) | Qualigen, Inc. | 2015-01-07 |
| DIAZYME HSCRP POC TEST KIT (K121558) | Diazyme Laboratories | 2012-09-21 |
| DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET (K103557) | Diazyme Laboratories | 2011-04-27 |
| ABX PENTRA 400 : CRP (K061138) | Horiba Abx | 2006-09-29 |
Recalls involving this device
No recalls on record reference this clearance.