510(k) K993853 ยท JIX Calibrator, Multi-Analyte Mixture
K-ASSAY MULTI-ANALYTE CALIBRATOR
| Applicant | Kamiya Biomedical Co., Seattle WA, US |
| Decision | Substantially Equivalent, Dec 27, 1999 |
| Received | Nov 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993853
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2017 | Kamiya Biomedical Company, LLC K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD
The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Al Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.