510(k) K981248 ยท GGN Plasma, Coagulation Control
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Apr 29, 1998 |
| Received | Apr 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981248
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.