510(k) K013900 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Dec 21, 2001 |
| Received | Nov 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013900
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.