510(k) K033127 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Oct 31, 2003 |
| Received | Sep 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033127
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.