510(k) K821963 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.
| Applicant | Intl. Immunoassay Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 27, 1982 |
| Received | Jul 1, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821963
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.