510(k) K911846 ยท JXA Kit, Screening, Urine
URI-THREE(TM), MODIFICATION
| Applicant | Culture Kits, Inc., Norwich NY, US |
| Decision | Substantially Equivalent, Oct 4, 1991 |
| Received | Apr 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911846
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.