510(k) K013195 ยท LTT Panels, Test, Susceptibility, Antimicrobial
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
| Applicant | Trek Diagnostic Systems, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Nov 7, 2001 |
| Received | Sep 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013195
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.