510(k) K934273 ยท DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Mar 21, 1994 |
| Received | Aug 31, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934273
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872
VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS an Terminated |
DMT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.