510(k) K823507 ยท DGC Ige, Antigen, Antiserum, Control
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY
| Applicant | Hybritech, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Dec 28, 1982 |
| Received | Nov 24, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823507
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.