510(k) K883001 ยท CZJ Igd, Antigen, Antiserum, Control
QM300 CALIBRATOR D PACK
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 22, 1988 |
| Received | Jul 18, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883001
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.