510(k) K946090 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
KODAK EKTACCHEM 950IRC ANALYZER
| Applicant | Clinical Diagnostic Systems, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 17, 1995 |
| Received | Dec 13, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946090
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2023 | Ortho-Clinical Diagnostics, INc. VITROS XT Chemistry Products ALKP Slides Open, Classified |
CJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.