510(k) K982639 ยท DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control
SPIFE URINE IFE
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Nov 4, 1998 |
| Received | Jul 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982639
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.