510(k) K120626 ยท CJY Azo Dye, Calcium
EON CALCIUM REGENT
| Applicant | Vital Diagnostics (Manufacturing) Ptyltd, Noble Park, AU |
| Decision | Substantially Equivalent, Aug 22, 2012 |
| Received | Mar 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120626
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2014 | Vital Diagnostics, Inc. Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use.
PN 55285
For the quantitative measurement of calcium in plasma and serum Terminated |
CJY | None listed |
| Jan 14, 2014 | Vital Diagnostics, Inc. Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use
PN: 1429
For the quantitative measurement of calcium in plasma and serum Terminated |
CJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.