510(k) K990783 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 25, 1999 |
| Received | Mar 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990783
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.