510(k) K063365 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE
| Applicant | Dade Behring, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Dec 8, 2006 |
| Received | Nov 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063365
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.