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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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