510(k) K081411 ยท JGS Electrode, Ion Specific, Sodium
VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jun 30, 2008 |
| Received | May 20, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081411
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2019 | Ortho-Clinical Diagnostics VITROS Chemistry Products Na+ Slides, Catalog Number 8379034
For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VI Terminated |
JGS | None listed |
| Dec 20, 2016 | Ortho-Clinical Diagnostics VITROS Na+ Slides, (UPN 10758750004812)
For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 Terminated |
JGS | None listed |
| Feb 25, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652
VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, Terminated |
JGS | None listed |
| Feb 25, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606
VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350 Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.