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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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