510(k) K000566 · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

Applicant	Ortho-Clinical Diagnostics, Inc., Rochester NY, US
Decision	Substantially Equivalent, Mar 9, 2000
Received	Feb 22, 2000
Type	Special
FDA record	Open on fda.gov

Recalls that name K000566

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.