510(k) K033948 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
| Applicant | Dade Behring, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Mar 1, 2004 |
| Received | Dec 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033948
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.