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FDA 510(k) Applications Submitted by BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K130860
03/28/2013
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
K130990
04/10/2013
VARIANT(TM) II TURBO HBA1C KIT - 2.0
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
K122472
08/14/2012
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
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