510(k) K971985 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
N-ASSAY TIA PLASMINOGEN TEST KIT
| Applicant | Crestat Diagnostics, Inc., Weston CT, US |
| Decision | Substantially Equivalent, Oct 20, 1997 |
| Received | May 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971985
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.