510(k) K914554 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
SPECIFIC IGE EIA-TURBO ASSAY
| Applicant | Ventrex Laboratories, Inc., Portland ME, US |
| Decision | Substantially Equivalent, Mar 13, 1992 |
| Received | Oct 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914554
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.