510(k) K030650 ยท CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
| Applicant | Uridynamics, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 14, 2003 |
| Received | Feb 28, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030650
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.