510(k) K063591 ยท JFY Enzymatic Method, Creatinine
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 15, 2006 |
| Received | Dec 1, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2018 | Ortho-Clinical Diagnostics VITROS Chemistry Products CREA Slides, Product Code 680 2584
Product Usage:
VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quant Terminated |
JFY | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584
VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VIT Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.