510(k) K860257 ยท CIG Diazo Colorimetry, Bilirubin
DIRECT BILIRUBIN
| Applicant | Pointe Scientific, Inc.,, Detroit MI, US |
| Decision | Substantially Equivalent, Feb 21, 1986 |
| Received | Jan 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860257
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.