510(k) K082141 ยท JIT Calibrator, Secondary
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10
| Applicant | Biokit, S.A., Barcelona, ES |
| Decision | Substantially Equivalent, Sep 3, 2008 |
| Received | Jul 30, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K082141
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.