510(k) K103037 ยท NGJ Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
IND URINARY TRACT INFECTION (UTI) TEST STRIPS
| Applicant | Ind Diagnostic, Inc., Delta, B.C., CA |
| Decision | Substantially Equivalent, Apr 17, 2012 |
| Received | Oct 14, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103037
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2023 | Universal Meditech Inc. HealthyWiser UriTest" UTI Test Strips REF 900-UTI Open, Classified |
NGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.