510(k) K110394 ยท JIX Calibrator, Multi-Analyte Mixture
ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
| Applicant | Vital Diagnostics (Manufacturing) Ptyltd, Noble Park, AU |
| Decision | Substantially Equivalent, Jun 9, 2011 |
| Received | Feb 11, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K110394
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.