510(k) K133197 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
| Applicant | Fujirebio Diagnostics,Inc., Seguin TX, US |
| Decision | Substantially Equivalent, Jan 17, 2014 |
| Received | Oct 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133197
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.