510(k) K061970 ยท JHR Radioimmunoassay, Immunoglobulins (D, E)
ELECSYS IGE II IMMUNOASSAY
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 31, 2006 |
| Received | Jul 12, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061970
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.