510(k) K161874 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Audit MicroControls Linearity DROP LQ Blood Glucose
| Applicant | Aalto Scientific, Ltd., Eatonton GA, US |
| Decision | Substantially Equivalent, Aug 10, 2016 |
| Received | Jul 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161874
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.