510(k) K811912 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
HELENA VMA-SMC CONTROL
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 23, 1981 |
| Received | Jul 1, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811912
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.