510(k) K980885 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Aug 21, 1998 |
| Received | Mar 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980885
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.