FDA 510(k) Applications Submitted by CHARLOTTE BAKER

FDA 510(k) Number Submission Date Device Name Applicant
K062838 09/21/2006 VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 ORTHO-CLINICAL DIAGNOSTICS
K033300 10/14/2003 VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K063143 10/16/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc.


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