510(k) K843110 ยท JIS Calibrator, Primary
ROCHE STANDARDS FOR CHOLESTEROL
| Applicant | Roche Diagnostic Systems, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 4, 1984 |
| Received | Aug 7, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843110
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.