510(k) K932728 ยท KNK Acid, Uric, Uricase (Colorimetric)
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Apr 25, 1994 |
| Received | Jun 7, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932728
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2016 | Ortho-Clinical Diagnostics VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD ---
For in vitro diagnostic use only. Terminated |
KNK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.