510(k) K972382 ยท CIG Diazo Colorimetry, Bilirubin
UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
| Applicant | Arrows Co., Ltd., Osaka, JP |
| Decision | Substantially Equivalent, Sep 14, 1998 |
| Received | Jun 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972382
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.