510(k) K895118 ยท CIG Diazo Colorimetry, Bilirubin
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
| 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 K895118
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.