510(k) K133550 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
| Applicant | Maine Standards Company, LLC, Cumberland Foreside ME, US |
| Decision | Substantially Equivalent, Feb 5, 2014 |
| Received | Nov 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133550
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.