510(k) K811695 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
HELENA FETAL-TEK 200 MARKER
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 1, 1981 |
| Received | Jun 16, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811695
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.