510(k) K912718 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ENZYME LINEARITY CONTROL
| Applicant | Phoenix Diagnostics, Inc., Medfield MA, US |
| Decision | Substantially Equivalent, Sep 6, 1991 |
| Received | Jun 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912718
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.