510(k) K152117 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Dropper hsCRP High Sensitivity CRP Control
| Applicant | Quantimetrix Corporation, Redondo Beach CA, US |
| Decision | Substantially Equivalent, Apr 21, 2016 |
| Received | Jul 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152117
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.