510(k) K855079 ยท CIG Diazo Colorimetry, Bilirubin
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Mar 5, 1986 |
| Received | Dec 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855079
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.