FDA 510(k) Applications Submitted by BIO-RAD, DIAGNOSTICS GRP.

FDA 510(k) Number Submission Date Device Name Applicant
K070848 03/28/2007 LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X BIO-RAD, DIAGNOSTICS GRP.
K072721 09/26/2007 LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC BIO-RAD, DIAGNOSTICS GRP.
K071319 05/10/2007 I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 BIO-RAD, DIAGNOSTICS GRP.
K100727 03/15/2010 LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK BIO-RAD, DIAGNOSTICS GRP.
K121794 06/19/2012 LIQUICHEK URINE CHEMISTRY CONTROL BIO-RAD, DIAGNOSTICS GRP.
K072835 10/03/2007 LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK BIO-RAD, DIAGNOSTICS GRP.


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