Medical Device Manufacturer · FR , Montpellier

Horiba Abx

19 submissions · 19 cleared · Since 2005
19
Total
19
Cleared
0
Denied

Horiba Abx — FDA 510(k) Submissions

Horiba Abx has submitted 19 FDA 510(k) premarket notifications since 2005, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Differential Cell, Hexokinase, Glucose, Urease And Glutamic Dehydrogenase, Urea Nitrogen, Mixture, Hematology Quality Control, Cresolphthalein Complexone, Calcium . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
K073309 · LCP Assay, Glycosylated... · Chemistry
Oct 2008 329d
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
K081276 · CFR Hexokinase, Glucose · Chemistry
Sep 2008 130d
ABX PENTRA URINE CAL
K071779 · JIX Calibrator, Multi-analyte... · Chemistry
Mar 2008 247d
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
K072115 · CGX Alkaline Picrate,... · Chemistry
Nov 2007 121d
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
K070146 · CDQ Urease And Glutamic... · Chemistry
Oct 2007 269d
CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K062737 · CGS Nad Reduction/nadh... · Chemistry
Jun 2007 272d
ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL
K060434 · CIX Bromcresol Green... · Chemistry
Jun 2007 469d
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
K070249 · CIC Cresolphthalein... · Chemistry
Apr 2007 90d
ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP
K062180 · JFJ Catalytic Methods, Amylase · Chemistry
Oct 2006 63d
ABX PENTRA 400 : CRP
K061138 · DCK C-reactive Protein,... · Chemistry
Sep 2006 158d
ABX PENTRA 400: LIPOPROTEINS
K060854 · JIT Calibrator, Secondary · Chemistry
Aug 2006 148d
ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P
K060325 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Aug 2006 188d
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060318 · CIT Nadh Oxidation/nad... · Chemistry
Aug 2006 181d
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060205 · CJE Nitrophenylphosphate,... · Chemistry
Jul 2006 176d
ABX MICROS CRP 200, OPTION IM
K053308 · GKZ Counter, Differential Cell · Hematology
Dec 2005 31d
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
K052007 · CFR Hexokinase, Glucose · Chemistry
Dec 2005 144d
CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
K050448 · GGP Test, Qualitative And... · Hematology
Sep 2005 213d
ABX ERYTROL
K050721 · JPK Mixture, Hematology... · Hematology
Jun 2005 72d
ABX PENTRA DX 120: OPTION SPS EVOLUTION
K050719 · GKZ Counter, Differential Cell · Hematology
Apr 2005 36d
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