510(k) K992312 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
| Applicant | Kamiya Biomedical Co., Seattle WA, US |
| Decision | Substantially Equivalent, Sep 13, 1999 |
| Received | Jul 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992312
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2006 | Kamiya Biomedical Company K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The Terminated |
DCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.