FDA 510(k) Applications Submitted by HORIBA ABX

FDA 510(k) Number Submission Date Device Name Applicant
K081276 05/05/2008 ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H HORIBA ABX
K071779 07/02/2007 ABX PENTRA URINE CAL HORIBA ABX
K072115 08/01/2007 ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H HORIBA ABX
K073309 11/23/2007 ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT HORIBA ABX
K070146 01/16/2007 ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP HORIBA ABX
K070249 01/26/2007 ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H HORIBA ABX
K060205 01/26/2006 GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER HORIBA ABX
K060318 02/08/2006 HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER HORIBA ABX
K060325 02/09/2006 ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P HORIBA ABX
K060434 02/21/2006 ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL HORIBA ABX
K050448 02/22/2005 CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 HORIBA ABX
K050719 03/21/2005 ABX PENTRA DX 120: OPTION SPS EVOLUTION HORIBA ABX
K050721 03/21/2005 ABX ERYTROL HORIBA ABX
K060854 03/29/2006 ABX PENTRA 400: LIPOPROTEINS HORIBA ABX
K061138 04/24/2006 ABX PENTRA 400 : CRP HORIBA ABX
K052007 07/25/2005 ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) HORIBA ABX
K062180 07/31/2006 ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP HORIBA ABX
K062737 09/13/2006 CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER HORIBA ABX
K053308 11/28/2005 ABX MICROS CRP 200, OPTION IM HORIBA ABX


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