510(k) K885285 ยท CIG Diazo Colorimetry, Bilirubin
DIRECT BILIRUBIN TEST CATALOG NO. SR1008
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jan 30, 1989 |
| Received | Dec 23, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885285
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.