510(k) K081915 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
FDTX GLUCOSE CONTROL SOLUTION
| Applicant | Fujirebio Diagnostics Texas, Inc., Seguin TX, US |
| Decision | Substantially Equivalent, Aug 8, 2008 |
| Received | Jul 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081915
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.