510(k) K882450 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.
| Applicant | Diamond Sensor Systems, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jul 28, 1988 |
| Received | Jun 14, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882450
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.