510(k) K230161 · MOJ Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)

ONLINE TDM Phenytoin - Free Phenytoin application

Applicant	Roche Diagnostics, Indianapolis IN, US
Decision	Substantially Equivalent, Mar 30, 2023
Received	Jan 20, 2023
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K230161

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.