510(k) K043384 · LDO Enzymatic Radiochemical Assay, Tobramycin

VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III

Applicant	Ortho-Clinical Diagnostics, Inc., Rochester NY, US
Decision	Substantially Equivalent, Feb 7, 2005
Received	Dec 9, 2004
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K043384

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.