510(k) K895119 ยท CIG Diazo Colorimetry, Bilirubin
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Oct 17, 1989 |
| Received | Aug 15, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895119
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.