510(k) K971858 ยท KQJ System, Fibrinogen Determination
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Oct 9, 1997 |
| Received | May 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971858
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.