510(k) K963534 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
SIGMA DIAGNOSTICS CREATININE REAGENT KIT
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Sep 30, 1996 |
| Received | Sep 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963534
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.