510(k) K982209 ยท GJA Test, Thrombin Time
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Oct 15, 1998 |
| Received | Jun 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982209
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.