510(k) K834031 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
FACTOR II DEFICIENT SUBSTRATE PLASMA
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 16, 1983 |
| Received | Nov 22, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834031
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.