510(k) K934071 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
KODAK EKTACHEM DT SLIDES (URCR)
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Mar 21, 1994 |
| Received | Aug 20, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934071
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2012 | Ortho-Clinical Diagnostics VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc. Rochester, NY -- Ortho-Clinical Diagno Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.