510(k) K800826 ยท KQJ System, Fibrinogen Determination
FIBRINOGEN SCREEN
| Applicant | Pacific Hemostasis, Mchenry IL, US |
| Decision | Substantially Equivalent, May 30, 1980 |
| Received | Apr 14, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800826
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2017 | Fisher Diagnostics Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC Terminated |
KQJ | None listed |
| May 19, 2017 | Fisher Diagnostics Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientif Terminated |
KQJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.