510(k) K894317 ยท JOX Analyzer, Heparin, Automated
HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
| Applicant | Hemotec, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Sep 5, 1989 |
| Received | Jul 14, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894317
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2010 | Medtronic Inc Medtronic HMS PLUS, Hemostasis Management System, Model 30514.
It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use ca Terminated |
JOX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.