510(k) K861055 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Apr 24, 1986 |
| Received | Mar 19, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861055
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.