510(k) K972796 ยท GJS Test, Time, Prothrombin
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Oct 10, 1997 |
| Received | Jul 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2004 | Trinity Biotech USA AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm on the label: Trinity Biotech PLC, I Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.