510(k) K981281 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS CALCHECK FERRITIN
| Applicant | Roche Diagnostics GmbH, Pleasanton CA, US |
| Decision | Substantially Equivalent, Apr 24, 1998 |
| Received | Apr 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981281
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.