510(k) K880828 ยท DFT Igm, Antigen, Antiserum, Control
WAKO(TM) IGM-HA DIRECT
| Applicant | Wako Chemicals USA, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Mar 25, 1988 |
| Received | Mar 1, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880828
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.