510(k) K010973 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000
| Applicant | Hypoguard USA, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Sep 11, 2001 |
| Received | Apr 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010973
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.