510(k) K845027 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Jan 18, 1985 |
| Received | Dec 27, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K845027
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2006 | Ortho-Clinical Diagnostics VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides p Terminated |
CHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.