510(k) K862704 ยท JIS Calibrator, Primary
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Aug 19, 1986 |
| Received | Jul 15, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862704
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.