510(k) K060678 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Sep 14, 2006 |
| Received | Mar 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060678
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.