510(k) K812028 ยท CEK Biuret (Colorimetric), Total Protein
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP)
| 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 K812028
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2003 | Ortho-Clinical Diagnostics Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label Terminated |
CEK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.