510(k) K131479 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 7, 2013 |
| Received | May 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131479
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.