510(k) K003329 ยท GGC Control, Plasma, Abnormal
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 1, 2001 |
| Received | Oct 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003329
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.