510(k) K881037 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
SPECTROLYSE/FIBRIN
| Applicant | Cytrx Biopool, Ltd., Norcross GA, US |
| Decision | Substantially Equivalent, Jul 1, 1988 |
| Received | Mar 11, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881037
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.