510(k) K162514 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Multichem A1c
| Applicant | Technopath Manufacturing, Ballina, IE |
| Decision | Substantially Equivalent, Oct 26, 2016 |
| Received | Sep 8, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K162514
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.