510(k) K201311 ยท LCO Platelet Factor 4 Radioimmunoassay
PF4 IgG assay
| Applicant | Immucor Gti Diagnostics, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Jun 18, 2020 |
| Received | May 18, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201311
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.