510(k) K812030 ยท CIX Bromcresol Green Dye-Binding, Albumin
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
| Applicant | Eastman Kodak Company, Walker MI, US |
| Decision | Substantially Equivalent, Aug 3, 1981 |
| Received | Jul 20, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211
VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 C Terminated |
CIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.