K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
FDA 510(k) clearance K023828 · decided 2003-02-04
Clearance details
- K-number
- K023828
- Device name
- K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
- Applicant
- Kamiya Biomedical Co.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-18
- Decision date
- 2003-02-04
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- DCK
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| "K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated cli recall (Z-0973-2010) | Kamiya Biomedical Company, LLC | 2010-03-04 |