510(k) K010158 ยท GGO Reagent, Thromboplastin And Control
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 22, 2001 |
| Received | Jan 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010158
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.