510(k) K941142 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Jun 13, 1994 |
| Received | Mar 10, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941142
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2018 | Ortho-Clinical Diagnostics VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic Terminated |
DIP | None listed |
| Jun 12, 2017 | Ortho-Clinical Diagnostics VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc.
For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively meas Terminated |
DIP | None listed |
| Nov 2, 2015 | Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products C Terminated |
JIT | None listed |
| Oct 2, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD.
For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) conc Terminated |
DIP | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671
VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/35 Terminated |
DIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.