510(k) K934413 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Apr 25, 1994 |
| Received | Sep 10, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934413
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815
VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VIT Terminated |
CIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.