510(k) K133003 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
RIGHTEST CONTROL SOLUTION
| Applicant | Bionime Corporation, Great Neck NY, US |
| Decision | Substantially Equivalent, Oct 24, 2013 |
| Received | Sep 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133003
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.