510(k) K930890 ยท DGC Ige, Antigen, Antiserum, Control
COBAS(R) CORE IGE TOTAL EIA
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Aug 5, 1993 |
| Received | Feb 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930890
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.