510(k) K861367 ยท KLS Enzyme Immunoassay, Theophylline
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, May 29, 1986 |
| Received | Apr 11, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164
VITROS THEO Slides quantitatively measure theophylline (T Terminated |
KLS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.