FDA 510(k) Applications Submitted by LEAH VAN DE WATER

FDA 510(k) Number Submission Date Device Name Applicant
K060632 03/09/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 Ortho-Clinical Diagnostics, Inc.
K060480 02/23/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS ORTHO-CLINICAL DIAGNOSTICS
K081543 06/02/2008 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM Ortho-Clinical Diagnostics, Inc.
K083173 10/27/2008 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM ORTHO-CLINICAL DIAGNOSTICS
K201312 05/18/2020 VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack Ortho Clinical Diagnostics


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