510(k) K991166 ยท JIX Calibrator, Multi-Analyte Mixture
K-ASSAY MICROALBUMIN CALIBRATOR SET
| Applicant | Kamiya Biomedical Co., Seattle WA, US |
| Decision | Substantially Equivalent, Jun 10, 1999 |
| Received | Apr 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991166
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.