510(k) K072288 ยท GHH Fibrin Split Products
PATHFAST D-DIMER
| Applicant | Mitsubishi Kagaku Iatron, Seattle WA, US |
| Decision | Substantially Equivalent, May 6, 2009 |
| Received | Aug 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072288
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2016 | Lsi Medience Corporation Pathfast D-Dimer, Reference number: PF1051-KUS Terminated |
GHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.