FDA 510(k) Applications Submitted by BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI

FDA 510(k) Number Submission Date Device Name Applicant
K080911 04/02/2008 VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
K063643 12/07/2006 MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
K070819 03/26/2007 VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI


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