510(k) K011972 ยท CIG Diazo Colorimetry, Bilirubin
DIRECT BILIRUBIN REAGENT
| Applicant | Intersect Systems, Inc., Longview WA, US |
| Decision | Substantially Equivalent, Aug 27, 2001 |
| Received | Jun 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011972
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.