FDA 510(k) Applications Submitted by HORIBA ABX S.A.S.

FDA 510(k) Number Submission Date Device Name Applicant
K110137 01/18/2011 ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN HORIBA ABX S.A.S.
K110530 02/24/2011 ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL HORIBA ABX S.A.S.
K123171 10/09/2012 ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT HORIBA ABX S.A.S.


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