510(k) K994100 ยท GJS Test, Time, Prothrombin
PACIFIC HEMOSTASIS THROMBOPLASTIN D
| Applicant | Pacific Hemostasis, Huntersville NC, US |
| Decision | Substantially Equivalent, Feb 18, 2000 |
| Received | Dec 3, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2025 | Fisher Diagnostics Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays. Open, Classified |
GJS | None listed |
| Mar 31, 2025 | Fisher Diagnostics Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays. Open, Classified |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.