510(k) K123930 ยท LPS Urinary Homocystine (Nonquantitative) Test System
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 15, 2013 |
| Received | Dec 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123930
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.