510(k) K061588 ยท LPS Urinary Homocystine (Nonquantitative) Test System
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jul 21, 2006 |
| Received | Jun 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061588
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002.
Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma. Terminated |
LPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.