510(k) K001133 ยท KHS Enzymatic, Carbon-Dioxide
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Apr 24, 2000 |
| Received | Apr 10, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396
VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VI Terminated |
KHS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.