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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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