510(k) K013126 ยท JIS Calibrator, Primary
N LP(A) STANDARD SY
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Nov 9, 2001 |
| Received | Sep 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013126
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.