510(k) K981278 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS CALCHECK CA 125II
| Applicant | Roche Diagnostics GmbH, Pleasanton CA, US |
| Decision | Substantially Equivalent, Apr 23, 1998 |
| Received | Apr 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981278
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.