510(k) K820772 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
| Applicant | Helena Laboratories, Walker MI, US |
| Decision | Substantially Equivalent, May 12, 1982 |
| Received | Mar 23, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820772
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.