510(k) K023828 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
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., Seattle WA, US |
| Decision | Substantially Equivalent, Feb 4, 2003 |
| Received | Nov 18, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023828
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2010 | Kamiya Biomedical Company, LLC "K-ASSAY CRP (3) Calibrator E".
This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbi Terminated |
DCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.