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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact