510(k) K033643 ยท JIT Calibrator, Secondary
CO2 CALIBRATOR/DILUENT
| Applicant | Bayer Healthcare, Diagnostics Division, Tarrytown NY, US |
| Decision | Substantially Equivalent, Jan 8, 2004 |
| Received | Nov 20, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K033643
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.