510(k) K163629 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Audit MicroControls Linearity FD Tumor Markers II
| Applicant | Aalto Scientific, Ltd., Eatonton GA, US |
| Decision | Substantially Equivalent, Mar 10, 2017 |
| Received | Dec 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163629
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.