510(k) K011043 ยท JXA Kit, Screening, Urine
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
| Applicant | Osmetech, Crewe, GB |
| Decision | Substantially Equivalent, Nov 30, 2001 |
| Received | Apr 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011043
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.