510(k) K913466 ยท CIG Diazo Colorimetry, Bilirubin
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Oct 25, 1991 |
| Received | Aug 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913466
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.