510(k) K883536 ยท DHR System, Test, Rheumatoid Factor
QM300 RHEUMATOID FACTOR ANTIGEN PACK
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 7, 1988 |
| Received | Aug 18, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883536
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.