510(k) K984289 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 12, 1999 |
| Received | Dec 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984289
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.