510(k) K020109 ยท GGC Control, Plasma, Abnormal
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Feb 6, 2002 |
| Received | Jan 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020109
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.