510(k) K011463 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Jun 13, 2001 |
| Received | May 14, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011463
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.