510(k) K820319 ยท JJS Controls For Blood-Gases, (Assayed And Unassayed)
FETAL-TEK CONTROL MATURE
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 25, 1982 |
| Received | Feb 5, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820319
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.