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Horiba Abx

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K073309 ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENTLCP2008-10-17 View
510(k) K081276 ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/HCFR2008-09-12 View
510(k) K071779 ABX PENTRA URINE CALJIX2008-03-05 View
510(k) K072115 ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/HCGX2007-11-30 View
510(k) K070146 ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPCDQ2007-10-12 View
510(k) K062737 CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERCGS2007-06-12 View
510(k) K060434 ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICALCIX2007-06-05 View
510(k) K070249 ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HCIC2007-04-26 View
510(k) K062180 ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CPJFJ2006-10-02 View
510(k) K061138 ABX PENTRA 400 : CRPDCK2006-09-29 View
510(k) K060854 ABX PENTRA 400: LIPOPROTEINSJIT2006-08-24 View
510(k) K060325 ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA PCIG2006-08-16 View
510(k) K060318 HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERCIT2006-08-08 View
510(k) K060205 GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERCJE2006-07-21 View
510(k) K053308 ABX MICROS CRP 200, OPTION IMGKZ2005-12-29 View
510(k) K052007 ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)CFR2005-12-16 View
510(k) K050448 CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5GGP2005-09-23 View
510(k) K050721 ABX ERYTROLJPK2005-06-01 View
510(k) K050719 ABX PENTRA DX 120: OPTION SPS EVOLUTIONGKZ2005-04-26 View
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