510(k) K833639 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
TITANGEL HIGH RESOLUTION CONTROL
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 4, 1984 |
| Received | Oct 17, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833639
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.