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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