510(k) K940082 ยท GJS Test, Time, Prothrombin
THROMBOSCREEN THROMBOPLASTIN-DS
| Applicant | Pacific Hemostasis, Huntersville NC, US |
| Decision | Substantially Equivalent, Feb 14, 1995 |
| Received | Jan 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2010 | Fisher Diagnostics, A Company of Fisher Scientific LLC Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company, Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.