510(k) K201570 ยท LCO Platelet Factor 4 Radioimmunoassay
PF4 Enhanced assay
| Applicant | Immucor Gti Diagnostics, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 11, 2020 |
| Received | Jun 11, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201570
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.