510(k) K852295 ยท JJW Urinalysis Controls (Assayed And Unassayed)
UROL-GUANT
| Applicant | Dimension Diagnostics, St. Charles MO, US |
| Decision | Substantially Equivalent, Jul 22, 1985 |
| Received | May 29, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852295
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.