510(k) K841503 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
KODAK EKTACHEM DT 60 ANALYZER
| Applicant | Eastman Kodak Company, 7600 Ridge Blvd Brooklun NY, US |
| Decision | Substantially Equivalent, May 22, 1984 |
| Received | Apr 10, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K841503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2006 | Ortho-Clinical Diagnostics VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and pla Terminated |
CGA | None listed |
| Sep 11, 2003 | Ortho-Clinical Diagnostics Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. , 100 Indigo Creek Dr., Rochester, NY 14626. [NOTE: product has a 24-month Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.